Trial Outcomes & Findings for Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation (NCT NCT01915498)
NCT ID: NCT01915498
Last Updated: 2024-10-22
Results Overview
Toxicity severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT was defined as: • Non-hematologic toxicities: CTCAE ≥ Grade 3 with the exception of ≥ Grade 3 blood bilirubin increases in participants with a uridine diphosphate- glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) mutation. In participants with a UGT1A1 mutation, blood bilirubin increases of \> 5× upper limit of normal (ULN) were considered a DLT. • Hematologic toxicities: Prolonged myelosuppression, defined as persistence of ≥ Grade 3 neutropenia or thrombocytopenia (by NCI CTCAE v4.03), leukemia-specific criteria, i.e., marrow cellularity \<5% on Day 28 or later from the start of study drug without evidence of leukemia) at least 42 days after the initiation of Cycle 1 therapy. Leukemia-specific grading was used for cytopenias (based on percentage decrease from Baseline: 50 to 75% = Grade 3, \>75% = Grade 4)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
345 participants
Primary outcome timeframe
From time of first dose up to the end of Cycle 1; 28 days
Results posted on
2024-10-22
Participant Flow
Participant milestones
| Measure |
Phase 1 Dose Escalation: Enasidenib 30 mg BID
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg BID
Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
Participants ≥ 60 years old with relapsed, refractory (R/R) AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 2: Enasidenib 100 mg QD
Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Safety Follow-Up: Enasidenib
Participants remaining on treatment as of the 01 September 2017 data cut-off date continued to receive enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Main Analysis (Sept 2013 - Sept 2017)
STARTED
|
7
|
7
|
7
|
8
|
5
|
9
|
7
|
22
|
6
|
14
|
9
|
5
|
7
|
49
|
25
|
25
|
27
|
106
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
3
|
0
|
2
|
3
|
6
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
NOT COMPLETED
|
7
|
7
|
7
|
8
|
5
|
9
|
7
|
21
|
6
|
14
|
9
|
4
|
7
|
46
|
25
|
23
|
24
|
100
|
0
|
|
Safety Follow-up (Sep 2017 to July 2019)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
|
Safety Follow-up (Sep 2017 to July 2019)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
|
Safety Follow-up (Sep 2017 to July 2019)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Safety Follow up (Aug 2019 to Sep 2023)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Safety Follow up (Aug 2019 to Sep 2023)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Safety Follow up (Aug 2019 to Sep 2023)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Phase 1 Dose Escalation: Enasidenib 30 mg BID
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg BID
Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
Participants ≥ 60 years old with relapsed, refractory (R/R) AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 2: Enasidenib 100 mg QD
Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Safety Follow-Up: Enasidenib
Participants remaining on treatment as of the 01 September 2017 data cut-off date continued to receive enasidenib on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Main Analysis (Sept 2013 - Sept 2017)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
5
|
1
|
2
|
2
|
5
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
2
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Medical Condition
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Development of Intercurrent Condition
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Bone Marrow Transplant (BMT)
|
1
|
2
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
6
|
5
|
2
|
2
|
9
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Miscellaneous
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
4
|
8
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Death
|
2
|
1
|
1
|
1
|
1
|
2
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
4
|
1
|
4
|
3
|
16
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Adverse Event
|
2
|
0
|
1
|
1
|
0
|
0
|
1
|
4
|
1
|
2
|
1
|
1
|
2
|
4
|
1
|
4
|
2
|
16
|
0
|
|
Main Analysis (Sept 2013 - Sept 2017)
Disease Progression
|
1
|
3
|
3
|
4
|
2
|
5
|
5
|
15
|
4
|
7
|
3
|
2
|
3
|
24
|
14
|
9
|
8
|
41
|
0
|
|
Safety Follow-up (Sep 2017 to July 2019)
Ongoing Treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Safety Follow up (Aug 2019 to Sep 2023)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Safety Follow up (Aug 2019 to Sep 2023)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Participants with available data.
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=7 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg BID
n=7 Participants
Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=7 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=8 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=5 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=9 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=7 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=22 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=6 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=14 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=9 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=7 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
n=49 Participants
Participants ≥ 60 years old with relapsed or refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=25 Participants
Participants \< 60 years old with relapsed, refractory AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
n=25 Participants
Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
n=27 Participants
Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 2: Enasidenib 100 mg QD
n=106 Participants
Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Total
n=345 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 6.37 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 8.86 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 8.38 • n=7 Participants
|
67.6 years
STANDARD_DEVIATION 12.88 • n=8 Participants
|
73.6 years
STANDARD_DEVIATION 7.23 • n=5 Participants
|
71.8 years
STANDARD_DEVIATION 9.00 • n=9 Participants
|
62.3 years
STANDARD_DEVIATION 13.77 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 15.06 • n=22 Participants
|
73.8 years
STANDARD_DEVIATION 2.48 • n=6 Participants
|
67.5 years
STANDARD_DEVIATION 14.69 • n=14 Participants
|
68.3 years
STANDARD_DEVIATION 6.20 • n=9 Participants
|
70.0 years
STANDARD_DEVIATION 8.77 • n=5 Participants
|
70.1 years
STANDARD_DEVIATION 5.34 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 11.09 • n=49 Participants
|
49.2 years
STANDARD_DEVIATION 8.12 • n=25 Participants
|
76.4 years
STANDARD_DEVIATION 6.87 • n=25 Participants
|
68.1 years
STANDARD_DEVIATION 13.96 • n=27 Participants
|
66.5 years
STANDARD_DEVIATION 11.88 • n=106 Participants
|
66.8 years
STANDARD_DEVIATION 12.49 • n=345 Participants
|
|
Age, Customized
< 65 Years Old
|
3 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=14 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=49 Participants
|
25 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
4 Participants
n=27 Participants
|
35 Participants
n=106 Participants
|
114 Participants
n=345 Participants
|
|
Age, Customized
≥ 65- < 75 Years Old
|
4 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=22 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=14 Participants
|
5 Participants
n=9 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
22 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
13 Participants
n=27 Participants
|
45 Participants
n=106 Participants
|
137 Participants
n=345 Participants
|
|
Age, Customized
≥ 75 Years Old
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=22 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=14 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
16 Participants
n=25 Participants
|
10 Participants
n=27 Participants
|
26 Participants
n=106 Participants
|
94 Participants
n=345 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=22 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=14 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
27 Participants
n=49 Participants
|
12 Participants
n=25 Participants
|
9 Participants
n=25 Participants
|
10 Participants
n=27 Participants
|
42 Participants
n=106 Participants
|
144 Participants
n=345 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=22 Participants
|
3 Participants
n=6 Participants
|
11 Participants
n=14 Participants
|
8 Participants
n=9 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=49 Participants
|
13 Participants
n=25 Participants
|
16 Participants
n=25 Participants
|
17 Participants
n=27 Participants
|
64 Participants
n=106 Participants
|
201 Participants
n=345 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=49 Participants
|
3 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=106 Participants
|
27 Participants
n=345 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=22 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=14 Participants
|
8 Participants
n=9 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
36 Participants
n=49 Participants
|
16 Participants
n=25 Participants
|
22 Participants
n=25 Participants
|
19 Participants
n=27 Participants
|
60 Participants
n=106 Participants
|
234 Participants
n=345 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=14 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=49 Participants
|
6 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
7 Participants
n=27 Participants
|
38 Participants
n=106 Participants
|
84 Participants
n=345 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=22 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=14 Participants
|
8 Participants
n=9 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
40 Participants
n=49 Participants
|
17 Participants
n=25 Participants
|
24 Participants
n=25 Participants
|
19 Participants
n=27 Participants
|
78 Participants
n=106 Participants
|
267 Participants
n=345 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=49 Participants
|
4 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=106 Participants
|
19 Participants
n=345 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
4 Participants
n=345 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=106 Participants
|
1 Participants
n=345 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=345 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=49 Participants
|
2 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
4 Participants
n=345 Participants
|
|
Race/Ethnicity, Customized
Not Provided
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=49 Participants
|
2 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
6 Participants
n=27 Participants
|
21 Participants
n=106 Participants
|
50 Participants
n=345 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully active
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=49 Participants
|
5 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
6 Participants
n=27 Participants
|
24 Participants
n=106 Participants
|
79 Participants
n=345 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Restricted but ambulatory
|
4 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=22 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=14 Participants
|
4 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
28 Participants
n=49 Participants
|
18 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
16 Participants
n=27 Participants
|
65 Participants
n=106 Participants
|
204 Participants
n=345 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 - Ambulatory but unable to work
|
2 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=14 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=49 Participants
|
2 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
5 Participants
n=27 Participants
|
16 Participants
n=106 Participants
|
61 Participants
n=345 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 - Limited self-care
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=345 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4 - Completely Disabled
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=345 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=106 Participants
|
1 Participants
n=345 Participants
|
|
Isocitrate dehydrogenase 2 (IDH2) Mutation Type
R140
|
6 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=22 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=14 Participants
|
9 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
37 Participants
n=49 Participants
|
18 Participants
n=25 Participants
|
17 Participants
n=25 Participants
|
21 Participants
n=27 Participants
|
80 Participants
n=106 Participants
|
259 Participants
n=345 Participants
|
|
Isocitrate dehydrogenase 2 (IDH2) Mutation Type
R172
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=49 Participants
|
7 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
5 Participants
n=27 Participants
|
26 Participants
n=106 Participants
|
84 Participants
n=345 Participants
|
|
Isocitrate dehydrogenase 2 (IDH2) Mutation Type
Unknown
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=345 Participants
|
|
Isocitrate dehydrogenase 2 (IDH2) Mutation Type
Missing
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
2 Participants
n=345 Participants
|
|
Uridine Diphosphate-Glucuronosyltransferase 1 Family, Polypeptide A1 (UGT1A1) Mutation Status
Heterozygous
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=22 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=27 Participants
|
20 Participants
n=106 Participants
|
27 Participants
n=345 Participants
|
|
Uridine Diphosphate-Glucuronosyltransferase 1 Family, Polypeptide A1 (UGT1A1) Mutation Status
Homozygous
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
1 Participants
n=27 Participants
|
10 Participants
n=106 Participants
|
16 Participants
n=345 Participants
|
|
Uridine Diphosphate-Glucuronosyltransferase 1 Family, Polypeptide A1 (UGT1A1) Mutation Status
Wild Type
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=27 Participants
|
20 Participants
n=106 Participants
|
22 Participants
n=345 Participants
|
|
Uridine Diphosphate-Glucuronosyltransferase 1 Family, Polypeptide A1 (UGT1A1) Mutation Status
Not Applicable
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=22 Participants
|
4 Participants
n=6 Participants
|
14 Participants
n=14 Participants
|
8 Participants
n=9 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
47 Participants
n=49 Participants
|
24 Participants
n=25 Participants
|
21 Participants
n=25 Participants
|
23 Participants
n=27 Participants
|
36 Participants
n=106 Participants
|
258 Participants
n=345 Participants
|
|
Uridine Diphosphate-Glucuronosyltransferase 1 Family, Polypeptide A1 (UGT1A1) Mutation Status
Missing
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=27 Participants
|
20 Participants
n=106 Participants
|
22 Participants
n=345 Participants
|
|
Cytogenetic Risk Status
Favorable-Risk
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=345 Participants
|
|
Cytogenetic Risk Status
Intermediate-Risk
|
4 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=22 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=14 Participants
|
6 Participants
n=9 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
19 Participants
n=49 Participants
|
14 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
19 Participants
n=27 Participants
|
57 Participants
n=106 Participants
|
173 Participants
n=345 Participants
|
|
Cytogenetic Risk Status
Poor-Risk
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=49 Participants
|
8 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
2 Participants
n=27 Participants
|
26 Participants
n=106 Participants
|
84 Participants
n=345 Participants
|
|
Cytogenetic Risk Status
Failure
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=106 Participants
|
9 Participants
n=345 Participants
|
|
Cytogenetic Risk Status
Missing
|
2 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=14 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=49 Participants
|
3 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
6 Participants
n=27 Participants
|
17 Participants
n=106 Participants
|
79 Participants
n=345 Participants
|
|
Bone Marrow Blasts
< 20% Blasts
|
1 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=22 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=49 Participants
|
6 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
16 Participants
n=27 Participants
|
22 Participants
n=106 Participants
|
86 Participants
n=345 Participants
|
|
Bone Marrow Blasts
20% to < 30% Blasts
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=49 Participants
|
2 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
2 Participants
n=27 Participants
|
14 Participants
n=106 Participants
|
34 Participants
n=345 Participants
|
|
Bone Marrow Blasts
30% to < 50% Blasts
|
5 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=22 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=14 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=49 Participants
|
4 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
3 Participants
n=27 Participants
|
18 Participants
n=106 Participants
|
69 Participants
n=345 Participants
|
|
Bone Marrow Blasts
≥ 50% Blasts
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=14 Participants
|
3 Participants
n=9 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
26 Participants
n=49 Participants
|
12 Participants
n=25 Participants
|
10 Participants
n=25 Participants
|
6 Participants
n=27 Participants
|
49 Participants
n=106 Participants
|
150 Participants
n=345 Participants
|
|
Bone Marrow Blasts
Missing
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=106 Participants
|
6 Participants
n=345 Participants
|
|
Malignancy Type
Relapsed / Refractory Acute Myeloid Leukemia (AML)
|
6 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=22 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=14 Participants
|
8 Participants
n=9 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
48 Participants
n=49 Participants
|
25 Participants
n=25 Participants
|
3 Participants
n=25 Participants
|
9 Participants
n=27 Participants
|
105 Participants
n=106 Participants
|
280 Participants
n=345 Participants
|
|
Malignancy Type
Untreated AML
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
22 Participants
n=25 Participants
|
5 Participants
n=27 Participants
|
1 Participants
n=106 Participants
|
39 Participants
n=345 Participants
|
|
Malignancy Type
Myelodysplastic Syndrome (MDS)
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
7 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
17 Participants
n=345 Participants
|
|
Malignancy Type
Other
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
6 Participants
n=27 Participants
|
0 Participants
n=106 Participants
|
9 Participants
n=345 Participants
|
|
Hemoglobin
|
82.0 g/L
n=7 Participants • Participants with available data.
|
97.0 g/L
n=7 Participants • Participants with available data.
|
86.0 g/L
n=7 Participants • Participants with available data.
|
97.5 g/L
n=8 Participants • Participants with available data.
|
91.0 g/L
n=5 Participants • Participants with available data.
|
89.0 g/L
n=9 Participants • Participants with available data.
|
92.0 g/L
n=7 Participants • Participants with available data.
|
96.5 g/L
n=22 Participants • Participants with available data.
|
94.0 g/L
n=6 Participants • Participants with available data.
|
87.5 g/L
n=14 Participants • Participants with available data.
|
93.0 g/L
n=9 Participants • Participants with available data.
|
103.0 g/L
n=5 Participants • Participants with available data.
|
95.0 g/L
n=7 Participants • Participants with available data.
|
93.0 g/L
n=49 Participants • Participants with available data.
|
93.0 g/L
n=25 Participants • Participants with available data.
|
89.0 g/L
n=25 Participants • Participants with available data.
|
92.0 g/L
n=27 Participants • Participants with available data.
|
89.0 g/L
n=105 Participants • Participants with available data.
|
90.0 g/L
n=344 Participants • Participants with available data.
|
|
Platelets
|
43.0 10^9 cells/L
n=7 Participants • Participants with available data
|
91.0 10^9 cells/L
n=7 Participants • Participants with available data
|
102.0 10^9 cells/L
n=7 Participants • Participants with available data
|
92.0 10^9 cells/L
n=8 Participants • Participants with available data
|
44.0 10^9 cells/L
n=5 Participants • Participants with available data
|
23.0 10^9 cells/L
n=9 Participants • Participants with available data
|
52.0 10^9 cells/L
n=7 Participants • Participants with available data
|
35.5 10^9 cells/L
n=22 Participants • Participants with available data
|
48.0 10^9 cells/L
n=6 Participants • Participants with available data
|
42.0 10^9 cells/L
n=14 Participants • Participants with available data
|
63.0 10^9 cells/L
n=9 Participants • Participants with available data
|
73.0 10^9 cells/L
n=5 Participants • Participants with available data
|
45.9 10^9 cells/L
n=7 Participants • Participants with available data
|
39.0 10^9 cells/L
n=49 Participants • Participants with available data
|
37.0 10^9 cells/L
n=25 Participants • Participants with available data
|
58.0 10^9 cells/L
n=25 Participants • Participants with available data
|
57.0 10^9 cells/L
n=27 Participants • Participants with available data
|
36.0 10^9 cells/L
n=105 Participants • Participants with available data
|
42.9 10^9 cells/L
n=344 Participants • Participants with available data
|
|
Absolute Neutrophil Count (ANC)
|
0.8 10^9 cells/L
n=7 Participants • Participants with available data
|
1.1 10^9 cells/L
n=6 Participants • Participants with available data
|
0.5 10^9 cells/L
n=6 Participants • Participants with available data
|
0.3 10^9 cells/L
n=8 Participants • Participants with available data
|
0.5 10^9 cells/L
n=5 Participants • Participants with available data
|
0.2 10^9 cells/L
n=9 Participants • Participants with available data
|
0.2 10^9 cells/L
n=7 Participants • Participants with available data
|
0.5 10^9 cells/L
n=22 Participants • Participants with available data
|
1.0 10^9 cells/L
n=6 Participants • Participants with available data
|
0.4 10^9 cells/L
n=12 Participants • Participants with available data
|
0.6 10^9 cells/L
n=9 Participants • Participants with available data
|
0.1 10^9 cells/L
n=5 Participants • Participants with available data
|
0.8 10^9 cells/L
n=7 Participants • Participants with available data
|
0.4 10^9 cells/L
n=49 Participants • Participants with available data
|
0.1 10^9 cells/L
n=25 Participants • Participants with available data
|
0.4 10^9 cells/L
n=23 Participants • Participants with available data
|
1.0 10^9 cells/L
n=27 Participants • Participants with available data
|
0.3 10^9 cells/L
n=105 Participants • Participants with available data
|
0.4 10^9 cells/L
n=338 Participants • Participants with available data
|
|
White Blood Cell Count
|
2.0 10^9 cells/L
n=7 Participants • Participants with available data
|
2.1 10^9 cells/L
n=7 Participants • Participants with available data
|
2.0 10^9 cells/L
n=7 Participants • Participants with available data
|
2.5 10^9 cells/L
n=8 Participants • Participants with available data
|
1.9 10^9 cells/L
n=5 Participants • Participants with available data
|
2.6 10^9 cells/L
n=9 Participants • Participants with available data
|
2.1 10^9 cells/L
n=7 Participants • Participants with available data
|
5.3 10^9 cells/L
n=22 Participants • Participants with available data
|
3.3 10^9 cells/L
n=6 Participants • Participants with available data
|
2.6 10^9 cells/L
n=14 Participants • Participants with available data
|
2.4 10^9 cells/L
n=9 Participants • Participants with available data
|
1.3 10^9 cells/L
n=5 Participants • Participants with available data
|
3.6 10^9 cells/L
n=7 Participants • Participants with available data
|
3.0 10^9 cells/L
n=49 Participants • Participants with available data
|
3.1 10^9 cells/L
n=25 Participants • Participants with available data
|
2.3 10^9 cells/L
n=25 Participants • Participants with available data
|
2.7 10^9 cells/L
n=27 Participants • Participants with available data
|
2.0 10^9 cells/L
n=105 Participants • Participants with available data
|
2.4 10^9 cells/L
n=344 Participants • Participants with available data
|
PRIMARY outcome
Timeframe: From time of first dose up to the end of Cycle 1; 28 daysPopulation: All participants who took at least one dose of study drug in the dose escalation phase and either had a DLT during Cycle 1, regardless of the amount of study drug exposure, or had no DLT and completed at least 75% of their planned Cycle 1 doses, and were considered to have had enough safety data to conclude that a DLT did not occur during Cycle 1.
Toxicity severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT was defined as: • Non-hematologic toxicities: CTCAE ≥ Grade 3 with the exception of ≥ Grade 3 blood bilirubin increases in participants with a uridine diphosphate- glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) mutation. In participants with a UGT1A1 mutation, blood bilirubin increases of \> 5× upper limit of normal (ULN) were considered a DLT. • Hematologic toxicities: Prolonged myelosuppression, defined as persistence of ≥ Grade 3 neutropenia or thrombocytopenia (by NCI CTCAE v4.03), leukemia-specific criteria, i.e., marrow cellularity \<5% on Day 28 or later from the start of study drug without evidence of leukemia) at least 42 days after the initiation of Cycle 1 therapy. Leukemia-specific grading was used for cytopenias (based on percentage decrease from Baseline: 50 to 75% = Grade 3, \>75% = Grade 4)
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=5 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=7 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=5 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=6 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=6 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=4 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=5 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the first dose of investigational product (IP) up to 28 days after the last dose, up to the data cutoff date of 01 September 2017; median treatment duration in the dose escalation phase was 5.0 months (range 0.4 to 34.2 months).Population: The safety analysis set includes all participants who received at least 1 dose of study treatment.
A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: • Resulted in death; • Was life threatening; • Requires inpatient hospitalization or prolongation of existing hospitalization; • Resulted in persistent or significant disability/incapacity; • Was a congenital anomaly/birth defect; • Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=7 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=7 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=8 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=5 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=9 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=7 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=22 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=6 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=14 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=9 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=7 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any treatment-emergent adverse event (TEAE)
|
7 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
7 Participants
|
22 Participants
|
6 Participants
|
14 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Related to Investigational Product (IP)
|
7 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
17 Participants
|
6 Participants
|
14 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Grade 3-4 TEAE
|
5 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
9 Participants
|
6 Participants
|
21 Participants
|
5 Participants
|
14 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Grade 3-4 TEAE Related to IP
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
10 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Grade 5 TEAE
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Grade 5 TEAE Related to IP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Serious TEAE
|
6 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
19 Participants
|
4 Participants
|
11 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Serious TEAE Related to IP
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Leading to Discontinuation (D/C) of IP
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Related to IP Leading to D/C of IP
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Leading to Reduction of IP
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Related to IP Leading to Reduction of IP
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Leading to Interruption of IP
|
1 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
10 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Related to IP Leading to Interruption of IP
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From the first dose of investigational product (IP) up to 28 days after the last dose of IP up to the data cutoff date of 01 September 2017; median treatment duration in Part 1 Expansion was 5.2 months (range 0.5 to 32.8 months).Population: All participants in Phase 1 Expansion who received at least 1 dose of study treatment.
A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: • Resulted in death; • Was life threatening; • Required inpatient hospitalization or prolongation of existing hospitalization; • Resulted in persistent or significant disability/incapacity; • Was a congenital anomaly/birth defect; • Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=25 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=49 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=25 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=27 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to Investigational Product (IP)
|
18 Participants
|
43 Participants
|
22 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Serious TEAE Related to IP
|
6 Participants
|
7 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Leading to Discontinuation (D/C) of IP
|
2 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to IP Leading to D/C of IP
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Leading to IP Interruption
|
10 Participants
|
24 Participants
|
16 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Any Treatment-emergent Adverse Event (TEAE)
|
24 Participants
|
49 Participants
|
25 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 TEAE
|
21 Participants
|
47 Participants
|
21 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 TEAE Related to IP
|
9 Participants
|
20 Participants
|
15 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Grade 5 TEAE
|
2 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Grade 5 TEAE Related to IP
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Serious TEAE
|
19 Participants
|
41 Participants
|
20 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Leading to Reduction of IP
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to IP Leading to Reduction of IP
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to IP Leading to Interruption of IP
|
3 Participants
|
9 Participants
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).Population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
ORR is defined as the percentage of participants achieving an overall response of complete response (CR), CR with incomplete neutrophil recovery (CRi), CR with incomplete platelet recovery (CRp), partial response (PR), or morphologic leukemia-free state (MLFS) based on the 2003 revised International Working Group (IWG) criteria for AML, assessed by the Investigator. CR: • Absolute neutrophil count (ANC) \> 1.0 x10⁹/L • Platelet count \> 100 x10⁹/L • Bone marrow (BM) blasts \< 5% • Absence of blasts with Auer rods • Independence of red cell transfusions CRi: • All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: • All CR criteria except for residual thrombocytopenia (platelets \< 100 x 10⁹/L) PR: • Meets hematologic criteria of CR • Decrease of BM blasts to 5-25% and decrease of pretreatment BM blast ≥ 50%. MLFS: • Bone marrow blasts \< 5% • Absence of blasts with Auer rods • Absence of extramedullary disease • No hematologic recovery required
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=105 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Investigator Assessed Overall Response Rate (ORR)
|
—
|
37.1 percentage of participants
Interval 27.9 to 47.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of investigational product (IP) up to 28 days after the last dose, up to the data cutoff of date of 01 September 2017; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).Population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment
A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: - Resulted in death; - Was life threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=105 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Any Treatment-emergent Adverse Event (TEAE)
|
—
|
105 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to Investigational Product (IP)
|
—
|
88 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 TEAE
|
—
|
92 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 TEAE Related to IP
|
—
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Grade 5 TEAE
|
—
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Grade 5 TEAE Related to IP
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Serious TEAE
|
—
|
85 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
Serious TEAE Related to IP
|
—
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Leading to Discontinuation (D/C) of IP
|
—
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to IP Leading to D/C of IP
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Leading to Reduction of IP
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to IP Leading to Reduction of IP
|
—
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Leading to Interruption of IP
|
—
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Dose Expansion: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to IP Leading to Interruption of IP
|
—
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the primary analysis cut-off date of 01 September 2017 to the final analysis cut-off date of 29 July 2019, a maximum of 23 months.Population: Participants who received at least 1 dose of study treatment during the Safety Follow-up Period.
A TEAE is any adverse event that began or worsened on or after the start of investigational product (IP) through 28 days after the last dose. A treatment-related TEAE is a TEAE that is suspected (possibly or probably related) by the Investigator to be related to the IP. A serious AE is one that at any dose of IP or at any time during the observation period met the following criteria: - Resulted in death; - Was life threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Was medically important. The intensity of each AE was graded from 1 to 5 according to the NCI CTCAE Version 4.03, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=16 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
—
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16 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 TEAE Related to IP
|
—
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3 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
TEAE Leading to Reduction of IP
|
—
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0 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to IP Leading to Reduction of IP
|
—
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0 Participants
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
TEAE Leading to Interruption of IP
|
—
|
4 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to IP Leading to D/C of IP
|
—
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0 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to IP Leading to Interruption of IP
|
—
|
0 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
TEAE Related to Investigational Product (IP)
|
—
|
6 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
Grade 3-4 TEAE
|
—
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13 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
Grade 5 TEAE
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—
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0 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
Grade 5 TEAE Related to IP
|
—
|
0 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
Serious TEAE
|
—
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9 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
Serious TEAE Related to IP
|
—
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1 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Safety Follow-up: Number of Participants With Treatment Emergent Adverse Events
TEAE Leading to Discontinuation (D/C) of IP
|
—
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0 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in the dose escalation phase was 5.0 months (range 0.4 to 34.2 months).Population: All participants who received at least one dose of study treatment in Phase 1 Dose Escalation. Participants were grouped according to assigned total daily dose.
ORR is defined as the percentage of participants achieving an overall response of CR, CRi, CRp, PR, marrow CR (mCR) (for MDS) and MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS. CR: • ANC \> 1.0 x10⁹/L • Platelet count \> 100 x10⁹/L • Bone marrow (BM) blasts \< 5% • Absence of blasts with Auer rods • Independence of red cell transfusions CRi: • All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: • All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L) PR: • Meets hematologic criteria of CR • Decrease of BM blasts to 5-25% and decrease of pretreatment BM blast ≥ 50%. MLFS: • Bone marrow blasts \< 5% • Absence of blasts with Auer rods • Absence of extramedullary disease • No hematologic recovery required mCR: • Bone marrow myeloblasts ≤ 5% and decreased by ≥ 50%
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=9 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=7 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=29 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=13 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=22 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=14 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=5 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=7 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase 1 Dose Escalation: Investigator Assessed Overall Response Rate (ORR) by Total Daily Dose
|
42.9 percentage of participants
Interval 9.9 to 81.6
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33.3 percentage of participants
Interval 7.5 to 70.1
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14.3 percentage of participants
Interval 0.4 to 57.9
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44.8 percentage of participants
Interval 26.4 to 64.3
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46.2 percentage of participants
Interval 19.2 to 74.9
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50.0 percentage of participants
Interval 28.2 to 71.8
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35.7 percentage of participants
Interval 12.8 to 64.9
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60.0 percentage of participants
Interval 14.7 to 94.7
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71.4 percentage of participants
Interval 29.0 to 96.3
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).Population: All participants who received at least one dose of study treatment in Phase 1 Expansion.
ORR is defined as the percentage of participants achieving an overall response of CR, CRi, CRp, PR, mCR (for MDS), or MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS. CR: - ANC \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CRi: - All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: - All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L) PR: - Meets hematologic criteria of CR - Decrease of BM blasts to 5-25% and decrease of pretreatment BM blast ≥ 50%. MLFS: - Bone marrow blasts \< 5% - Absence of blasts with Auer rods - Absence of extramedullary disease - No hematologic recovery required mCR: - Bone marrow myeloblasts ≤ 5% and decreased by ≥ 50%
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=25 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=49 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=25 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=27 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase 1 Dose Expansion: Investigator Assessed Overall Response Rate (ORR)
|
20.0 percentage of participants
Interval 6.8 to 40.7
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46.9 percentage of participants
Interval 32.5 to 61.7
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36.0 percentage of participants
Interval 18.0 to 57.5
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44.4 percentage of participants
Interval 25.5 to 64.7
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—
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—
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—
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SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure for Phase 1 and 2 R/R AML participants was 5.4 months (range 0.4 to 34.2 months).Population: All participants in Phase 1 and 2 with R/R AML who received at least one dose of study treatment.
For participants with R/R AML ORR is defined as the percentage of participants achieving an overall response of CR, CRi, CRp, PR, or MLFS based on the 2003 revised IWG criteria for AML. CR: - ANC \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CRi: - All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: - All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L) PR: - Meets hematologic criteria of CR - Decrease of BM blasts to 5-25% and decrease of pretreatment BM blast ≥ 50%. MLFS: - Bone marrow blasts \< 5% - Absence of blasts with Auer rods - Absence of extramedullary disease - No hematologic recovery required
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=214 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Combined Phase 1/2: Investigator Assessed Overall Response Rate in Participants With R/R AML
|
—
|
38.8 percentage of participants
Interval 32.2 to 45.7
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Escalation was 5.0 months (range 0.4 to 34.2 months).Population: All participants who received at least one dose of study treatment in Phase 1 Dose Escalation. Participants were grouped according to assigned total daily dose.
Complete response rate is defined as the percentage of participants achieving a complete response (CR) based on the 2003 revised IWG criteria for AML or the 2006 modified IWG criteria for MDS as assessed by the investigator. CR for AML: - Absolute neutrophil count (ANC) \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CR for MDS: - Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines - Peripheral blood: -- Hemoglobin ≥ 11 g/dL -- Platelets ≥ 100 × 10⁹/L -- Neutrophils ≥ 1.0 × 10⁹/L -- Blasts = 0%
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=9 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=7 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
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Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=29 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=13 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=22 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=14 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=5 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=7 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase 1 Dose Escalation: Complete Response Rate (CRR) by Total Daily Dose
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
27.6 percentage of participants
Interval 12.7 to 47.2
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15.4 percentage of participants
Interval 1.9 to 45.4
|
4.5 percentage of participants
Interval 0.1 to 22.8
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21.4 percentage of participants
Interval 4.7 to 50.8
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).Population: All participants in Phase 1 Dose Expansion who received at least one dose of study treatment.
Complete response rate is defined as the percentage of participants achieving a complete response (CR) based on the 2003 revised IWG criteria for AML or the 2006 modified IWG criteria for MDS as assessed by the investigator. CR for AML: - Absolute neutrophil count (ANC) \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CR for MDS: - Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines - Peripheral blood: -- Hemoglobin ≥ 11 g/dL -- Platelets ≥ 100 × 10⁹/L -- Neutrophils ≥ 1.0 × 10⁹/L -- Blasts = 0%
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=25 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=49 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=25 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=27 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Complete Response Rate
|
0.0 percentage of participants
Interval 0.0 to 13.7
|
22.4 percentage of participants
Interval 11.8 to 36.6
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
22.2 percentage of participants
Interval 8.6 to 42.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).Population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
Complete response rate is defined as the percentage of participants achieving a complete response (CR) based on the 2003 revised IWG criteria for AML as assessed by the investigator. CR for AML: - Absolute neutrophil count (ANC) \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=105 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Complete Response Rate
|
—
|
20.0 percentage of participants
Interval 12.8 to 28.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in the Phase 1 Dose Escalation was 5.0 months (range 0.4 to 34.2 months).Population: All participants who received at least one dose of study treatment in Phase 1 Dose Escalation. Participants were grouped according to assigned total daily dose.
The percentage of participants achieving a complete response (CR), CR with incomplete neutrophil recovery (CRi), or a CR with incomplete platelet recovery (CRp), based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS per investigator review. CR: - ANC \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CRi: - All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: - All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L)
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=9 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=7 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=29 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=13 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=22 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=14 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=5 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=7 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation: Rate of Complete Response and Complete Response With Incomplete Hematological Recovery (CR/CRi/CRp) by Total Daily Dose
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
31.0 percentage of participants
Interval 15.3 to 50.8
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
18.2 percentage of participants
Interval 5.2 to 40.3
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).Population: All participants who received at least one dose of study treatment in Phase 1 Dose Expansion.
The percentage of participants achieving a complete response (CR), CR with incomplete neutrophil recovery (CRi), or a CR with incomplete platelet recovery (CRp) based on the 2003 revised IWG criteria for AML or the 2006 modified IWG criteria for MDS, assessed by the investigator. CR: - ANC \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CRi: - All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: - All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L)
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=25 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=49 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=25 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=27 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Rate of Complete Response and Complete Responses With Incomplete Hematological Recovery (CR/CRi/CRp)
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
28.6 percentage of participants
Interval 16.6 to 43.3
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
25.9 percentage of participants
Interval 11.1 to 46.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).Population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
The percentage of participants achieving a complete response (CR), CR with incomplete neutrophil recovery (CRi), or a CR with incomplete platelet recovery (CRp) based on the 2003 revised IWG criteria for AML, assessed by the Investigator. CR: - ANC \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CRi: - All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: - All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L)
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=105 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Rate of Complete Response and Complete Responses With Incomplete Hematological Recovery (CR/CRi/CRp)
|
—
|
31.4 percentage of participants
Interval 22.7 to 41.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the data cut-off date of 01 September 2017; overall median time on follow-up in Phase 1 Dose Expansion was 8.3 months (range 0.5 to 32.8 months).Population: Participants who received at least one dose of study treatment in Phase 1 Dose Expansion with an objective response.
Among participants who had a response of CR, CRi, CRp, PR, mCR, or MLFS based on the 2003 revised IWG criteria for AML or the 2006 modified IWG criteria for MDS, assessed by the Investigator, duration of response was calculated from the date of the first occurrence of response to the date of documented disease relapse, progression, or death due to any cause, whichever occurred first. DOR was estimated using the Kaplan-Meier method. Participants without relapse, progressive disease, or death due to any cause were censored at the date of the last adequate response assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=5 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=23 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=12 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Kaplan-Meier Estimate of Duration of Response (DOR)
|
3.9 months
Interval 1.9 to 5.1
|
5.6 months
Interval 1.9 to 18.5
|
NA months
Interval 1.9 to
Not estimable due to low number of events
|
12.0 months
Interval 0.4 to
Not estimable due to low number of events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).Population: Participants in Phase 2 with R/R AML who received at least one dose of study treatment and who had an objective response.
For participants with an objective response based on the 2003 revised IWG criteria for AML assessed by the Investigator, duration of response was calculated from the date of the first occurrence of response to the date of documented disease relapse, progression, or death due to any cause, whichever occurred first. Participants without relapse, progressive disease or death were censored at the last response assessment date. Relapse (for participants who previously attained CR, Cri, CRp or MLFS): BM blasts ≥ 5%, reappearance of blasts in the blood or development of extramedullary disease. Disease progression (for participants who previously attained PR): development of new extramedullary disease, or For participants with 5% to 67% BM blasts at nadir: - a \> 50% increase in BM blasts from nadir and that is ≥ 20%. For participants with ≥ 67% BM blasts at nadir: - a doubling of the nadir absolute peripheral blood (PB) blast count and the final absolute PB blast count \> 10 x 10⁹/L.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=39 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Kaplan-Meier Estimate of Duration of Response
|
—
|
5.6 months
Interval 3.7 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the data cut-off date of 01 September 2017; overall median time on follow-up in Phase 1 Dose Expansion was 8.3 months (range 0.5 to 32.8 months).Population: All participants in Phase 1 Dose Expansion who received at least one dose of study treatment.
Overall survival is defined as the time from first dose to the date of death due to any cause. Participants still alive were censored at the last date known to be alive or at the data cut-off date, whichever was earlier.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=25 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=49 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=25 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=27 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Kaplan-Meier Estimate of Overall Survival
|
11.6 months
Interval 6.5 to 15.4
|
8.8 months
Interval 7.5 to 10.5
|
10.6 months
Interval 6.2 to 19.8
|
11.3 months
Interval 3.6 to 19.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).Population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
Overall survival is defined as the time from first dose to the date of death due to any cause. Participants still alive were censored at the last date known to be alive or at the data cut-off date, whichever was earlier.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=105 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Kaplan-Meier Estimate of Overall Survival
|
—
|
7.0 months
Interval 4.9 to 8.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment; overall median duration of treatment exposure in Phase 1 combined was 5.1 months (range 0.4, 34.2 months).Population: The population included all participants who received at least one dose of study treatment in Phase 1 Dose Escalation and Dose Expansion. Results were analyzed and are reported for Phase 1 combined.
Participants who achieved 56-day post-baseline red blood cell (RBC) transfusion independence, i.e. with no RBC transfusions for at least 56 consecutive days during the treatment exposure period, reported by Baseline RBC transfusion dependence status. Participants with at least one transfusion during the Baseline period were considered transfusion dependent at Baseline, where the Baseline period is defined as 28 days before and 28 days after the first dose of treatment for Phase 1. Results are reported for all participants in Phase 1 combined and for the subset of participants with R/R AML.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=239 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=175 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Combined: Percentage of Participants Who Achieved 56-Day Red Blood Cell Transfusion Independence Post-baseline
Baseline Transfusion Dependent
|
38.5 percentage of participants
|
39.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Combined: Percentage of Participants Who Achieved 56-Day Red Blood Cell Transfusion Independence Post-baseline
Baseline Transfusion Independent
|
71.9 percentage of participants
|
80.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment; overall median duration of treatment exposure in Phase 1 combined was 5.1 months (range 0.4, 34.2 months).Population: The population included all participants who received at least one dose of study treatment in Phase 1 Dose Escalation and Dose Expansion. Results were analyzed and are reported for Phase 1 combined.
Participants who achieved 56-day post-baseline platelet transfusion independence, i.e. with no platelet transfusions for at least 56 consecutive days during the treatment exposure period, reported by Baseline platelet transfusion dependence status. Participants with at least one transfusion during the Baseline period were considered transfusion dependent at Baseline, where the Baseline period is defined as 28 days before and 28 days after the first dose of treatment for Phase 1. Results are reported for all participants in Phase 1 combined and for the subset of participants with R/R AML.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=239 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=175 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Combined: Percentage of Participants Who Achieved 56-Day Platelet Transfusion Independence Post-baseline
Baseline Transfusion Dependent
|
33.1 percentage of participants
|
38.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 Combined: Percentage of Participants Who Achieved 56-Day Platelet Transfusion Independence Post-baseline
Baseline Transfusion Independent
|
76.7 percentage of participants
|
78.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).Population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
Participants who achieved 56-day post-baseline red blood cell (RBC) transfusion independence, i.e. with no RBC transfusions for at least 56 consecutive days during the treatment exposure period, reported by Baseline RBC transfusion dependence status. Participants with at least one transfusion during the Baseline period were considered transfusion dependent at Baseline, where the Baseline period is defined as 56 days before the first dose date for Phase 2.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=105 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants Who Achieved 56-Day Red Blood Cell Transfusion Independence Post-baseline
Baseline Transfusion Dependent
|
—
|
41.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Percentage of Participants Who Achieved 56-Day Red Blood Cell Transfusion Independence Post-baseline
Baseline Transfusion Independent
|
—
|
57.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).Population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
Participants who achieved 56-day post-baseline platelet transfusion independence, i.e. with no platelet transfusions for at least 56 consecutive days during the treatment exposure period, reported by Baseline platelet transfusion dependence status. Participants with at least one transfusion during the Baseline period were considered transfusion dependent at Baseline, where the Baseline period is defined as 56 days before the first dose date for Phase 2.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=105 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants Who Achieved 56-Day Platelet Transfusion Independence Post-baseline
Baseline Transfusion Dependent
|
—
|
35.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Percentage of Participants Who Achieved 56-Day Platelet Transfusion Independence Post-baseline
Baseline Transfusion Independent
|
—
|
69.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the data cut-off date of 01 September 2017; overall median time on follow-up in Phase 1 Dose Expansion was 8.3 months (range 0.5 to 32.8 months).Population: All participants in Phase 1 Dose Expansion who received at least one dose of study treatment.
Event-free survival is defined as the interval from the date of the first dose to the date of documented relapse, progression, or death due to any cause, whichever occurs first. Participants without an EFS event were censored at the date of the last adequate response assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=25 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=49 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=25 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=27 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Kaplan-Meier Estimate of Event Free Survival (EFS)
|
3.8 months
Interval 2.6 to 8.8
|
4.0 months
Interval 3.8 to 7.0
|
9.2 months
Interval 2.8 to
Not estimable due to the low number of events
|
3.8 months
Interval 1.8 to 11.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).Population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
Event-free survival is defined as the interval from the date of the first dose to the date of documented relapse, progression, or death due to any cause, whichever occurred first. Participants without an EFS event were censored at the date of the last adequate response assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=105 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Kaplan-Meier Estimate of Event Free Survival
|
—
|
4.7 months
Interval 3.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the data cut-off date of 01 September 2017; overall median time on follow-up in Phase 1 Dose Expansion was 8.3 months (range 0.5 to 32.8 months).Population: Participants who received at least one dose of study treatment in Phase 1 Dose Expansion with a complete response.
Among participants who had a response of CR based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS assessed by the Investigator, duration of complete response was calculated from the date of the first occurrence of complete response to the date of documented disease relapse, progression or death, whichever occurred earlier. DOCR was estimated using the Kaplan-Meier method. Participants without relapse, progressive disease, or death due to any cause were censored at the date of the last adequate response assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=11 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=6 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Kaplan-Meier Estimate of Duration of Complete Response (DOCR)
|
—
|
11.6 months
Interval 1.9 to
Not estimable due to low number of events
|
NA months
Interval 3.7 to
Not estimable due to low number of events
|
16.8 months
Interval 2.6 to
Not estimable due to low number of events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).Population: Participants in Phase 2 with R/R AML who received at least one dose of study treatment and who had a complete response.
Among participants who had a response of CR based on the 2003 revised IWG criteria for AML assessed by the Investigator, duration of complete response was calculated from the date of the first occurrence of complete response to the date of documented disease relapse, progression or death, whichever occurred earlier. DOCR was estimated using the Kaplan-Meier method. Participants without relapse, progressive disease, or death due to any cause were censored at the date of the last adequate response assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=21 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Duration of Complete Response
|
—
|
4.6 months
Interval 2.8 to 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Escalation was 5.0 months (range 0.4 to 34.2 months).Population: Participants who received at least one dose of study treatment in Phase 1 Dose Escalation who had an objective response. Participants were grouped according to assigned total daily dose.
Time to response is defined as the time from the date of first dose to the date of the first occurrence of response of CR, CRi, CRp, PR, mCR (for MDS) or MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS as assessed by the Investigator.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=3 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=3 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=1 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=13 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=6 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=5 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=3 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=5 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation: Time to First Response by Total Daily Dose
|
1.9 months
Interval 1.0 to 3.8
|
3.8 months
Interval 1.0 to 4.2
|
0.9 months
Interval 0.9 to 0.9
|
1.8 months
Interval 0.6 to 5.6
|
2.0 months
Interval 0.6 to 8.6
|
1.9 months
Interval 0.5 to 5.7
|
2.1 months
Interval 1.0 to 3.7
|
2.8 months
Interval 0.5 to 3.8
|
1.9 months
Interval 0.5 to 3.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).Population: Participants who received at least one dose of study treatment in Phase 1 Dose Expansion who had an objective response.
Time to response is defined as the time from the date of first dose to the date of the first occurrence of response of CR, CRi, CRp, PR, mCR (for MDS) or MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS as assessed by the Investigator.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=5 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=23 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=12 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Time to First Response
|
3.7 months
Interval 0.9 to 5.5
|
1.9 months
Interval 0.5 to 9.4
|
1.8 months
Interval 1.0 to 3.8
|
1.4 months
Interval 0.5 to 9.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).Population: Participants in Phase 2 with R/R AML who received at least one dose of study treatment and who had an objective response.
Time to response is defined as the time from the date of first dose to the date of the first occurrence of response of CR, CRi, CRp, PR, or MLFS based on the 2003 revised IWG criteria for AML as assessed by the Investigator.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=39 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Time to First Response
|
—
|
2.7 months
Interval 0.9 to 7.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Escalation was 5.0 months (range 0.4 to 34.2 months).Population: Participants who received at least one dose of study treatment in Phase 1 Dose Escalation and who had an objective response. Participants were grouped according to assigned total daily dose.
Time to best response is defined as the time from the date of the first dose to the date of the first occurrence of best response according to the following hierarchical order: CR, CRi/CRp, PR, mCR (for MDS) / MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS per investigator assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=3 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=3 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=1 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=13 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=6 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=5 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=3 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=5 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation: Time to Best Response by Total Daily Dose
|
2.9 months
Interval 1.0 to 3.8
|
4.2 months
Interval 3.8 to 5.6
|
0.9 months
Interval 0.9 to 0.9
|
2.0 months
Interval 0.6 to 9.2
|
3.8 months
Interval 0.6 to 9.7
|
1.9 months
Interval 0.5 to 5.7
|
3.8 months
Interval 2.1 to 7.5
|
3.7 months
Interval 0.5 to 3.8
|
1.9 months
Interval 0.5 to 3.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Part 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).Population: Participants who received at least one dose of study treatment in Phase 1 Dose Expansion who had an objective response.
Time to best response is defined as the time from the date of the first dose to the date of the first occurrence of best response according to the following hierarchical order: CR, CRi/CRp, PR, mCR (for MDS) / MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS per investigator assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=5 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=23 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=12 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Time to Best Response
|
3.7 months
Interval 0.9 to 5.5
|
3.7 months
Interval 0.9 to 11.2
|
3.7 months
Interval 1.8 to 12.9
|
4.6 months
Interval 0.6 to 14.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).Population: Participants in Phase 2 with R/R AML who received at least one dose of study treatment and who had an objective response.
Time to best response is defined as the time from the date of the first dose to the date of the first occurrence of best response according to the following hierarchical order: CR, CRi/CRp, PR, or MLFS based on the 2003 revised IWG criteria for AML per investigator assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=39 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Time to Best Response
|
—
|
3.7 months
Interval 0.9 to 12.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in the Phase 1 Dose Escalation phase was 5.0 months (range 0.4 to 34.2 months).Population: Participants who received at least one dose of study treatment in Phase 1 Dose Escalation with a complete response. Participants were grouped according to assigned total daily dose.
Time to complete response is defined as the time from the date of the first dose to the date of the first complete response based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS per investigator assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=1 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=2 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=8 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=2 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=1 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=3 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=2 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation: Time to Complete Response by Total Daily Dose
|
2.9 months
Interval 2.9 to 2.9
|
4.9 months
Interval 4.2 to 5.6
|
—
|
3.6 months
Interval 0.7 to 9.2
|
6.8 months
Interval 3.8 to 9.7
|
0.6 months
Interval 0.6 to 0.6
|
4.7 months
Interval 3.8 to 7.5
|
3.8 months
Interval 3.7 to 3.8
|
2.1 months
Interval 0.5 to 3.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Part 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).Population: Participants who received at least one dose of study treatment in Phase 1 Dose Expansion who had a complete response.
Time to complete response is defined as the time from the date of the first dose to the date of the first complete response based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS per investigator assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=11 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=6 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Expansion: Time to Complete Response
|
—
|
3.7 months
Interval 1.0 to 11.2
|
5.6 months
Interval 3.4 to 12.9
|
9.4 months
Interval 1.8 to 14.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).Population: Participants in Phase 2 with R/R AML who received at least one dose of study treatment and who had a complete response.
Time to complete response is defined as the time from the date of the first dose to the date of the first complete response based on the 2003 revised IWG criteria for AML per investigator assessment.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=21 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Dose Expansion: Time to Complete Response
|
—
|
3.7 months
Interval 0.9 to 12.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Dose Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for assessment of enasidenib pharmacokinetics (PK). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=58 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma Concentration Time Curve From Time Zero to 8 Hours Postdose (AUC0-8) of Enasidenib After a Single Oral Dose on Day -3
|
3020 ng*h/mL
Geometric Coefficient of Variation 58.4
|
3364 ng*h/mL
Geometric Coefficient of Variation 59.7
|
5319 ng*h/mL
Geometric Coefficient of Variation 57.0
|
6634 ng*h/mL
Geometric Coefficient of Variation 79.6
|
9397 ng*h/mL
Geometric Coefficient of Variation 32.1
|
11550 ng*h/mL
Geometric Coefficient of Variation 49.2
|
15268 ng*h/mL
Geometric Coefficient of Variation 42.0
|
15039 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
31580 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 10 hours post-dose (AUC0-10) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=57 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma Concentration Time Curve From Time Zero to 10 Hours Postdose (AUC0-10) of Enasidenib After a Single Oral Dose on Day -3
|
3925 ng*h/mL
Geometric Coefficient of Variation 58.4
|
4120 ng*h/mL
Geometric Coefficient of Variation 61.5
|
6834 ng*h/mL
Geometric Coefficient of Variation 54.1
|
8616 ng*h/mL
Geometric Coefficient of Variation 76.5
|
11819 ng*h/mL
Geometric Coefficient of Variation 31.3
|
14818 ng*h/mL
Geometric Coefficient of Variation 49.2
|
20727 ng*h/mL
Geometric Coefficient of Variation 41.0
|
19961 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
38711 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=56 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Enasidenib After a Single Oral Dose on Day -3
|
9611 ng*h/mL
Geometric Coefficient of Variation 59.6
|
8987 ng*h/mL
Geometric Coefficient of Variation 72.1
|
17330 ng*h/mL
Geometric Coefficient of Variation 50.6
|
21656 ng*h/mL
Geometric Coefficient of Variation 55.6
|
28989 ng*h/mL
Geometric Coefficient of Variation 29.6
|
37703 ng*h/mL
Geometric Coefficient of Variation 48.3
|
58743 ng*h/mL
Geometric Coefficient of Variation 41.5
|
60846 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 72 hours post-dose (AUC0-72) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=3 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=8 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=51 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=9 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=1 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma Concentration Time Curve From Time Zero to 72 Hours Postdose (AUC0-72) of Enasidenib After a Single Oral Dose on Day -3
|
20598 ng*h/mL
Geometric Coefficient of Variation 79.9
|
19192 ng*h/mL
Geometric Coefficient of Variation 138.4
|
37737 ng*h/mL
Geometric Coefficient of Variation 53.9
|
58670 ng*h/mL
Geometric Coefficient of Variation 59.5
|
76820 ng*h/mL
Geometric Coefficient of Variation 31.2
|
95217 ng*h/mL
Geometric Coefficient of Variation 57.2
|
160083 ng*h/mL
Geometric Coefficient of Variation 12.0
|
244130 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=58 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Enasidenib After a Single Oral Dose on Day -3
|
19975 ng*h/mL
Geometric Coefficient of Variation 68.6
|
17575 ng*h/mL
Geometric Coefficient of Variation 105.1
|
39345 ng*h/mL
Geometric Coefficient of Variation 51.9
|
53018 ng*h/mL
Geometric Coefficient of Variation 74.2
|
76820 ng*h/mL
Geometric Coefficient of Variation 31.2
|
95959 ng*h/mL
Geometric Coefficient of Variation 50.5
|
134094 ng*h/mL
Geometric Coefficient of Variation 32.6
|
157042 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
38711 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=58 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Concentration of Enasidenib After a Single Oral Dose on Day -3
|
545 ng/mL
Geometric Coefficient of Variation 64.0
|
569 ng/mL
Geometric Coefficient of Variation 45.6
|
1084 ng/mL
Geometric Coefficient of Variation 51.6
|
1279 ng/mL
Geometric Coefficient of Variation 56.1
|
1624 ng/mL
Geometric Coefficient of Variation 29.5
|
2082 ng/mL
Geometric Coefficient of Variation 46.5
|
3358 ng/mL
Geometric Coefficient of Variation 43.1
|
3031 ng/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
4670 ng/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=58 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Maximum Concentration (Tmax) of Enasidenib After a Single Oral Dose on Day -3
|
5.83 hours
Interval 1.92 to 24.25
|
1.59 hours
Interval 1.0 to 4.08
|
3.00 hours
Interval 1.13 to 21.42
|
4.00 hours
Interval 0.67 to 71.97
|
3.98 hours
Interval 2.0 to 24.0
|
4.08 hours
Interval 1.0 to 48.55
|
8.89 hours
Interval 2.95 to 72.17
|
18.61 hours
Interval 13.33 to 23.88
|
6.17 hours
Interval 6.17 to 6.17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. T1/2 was not calculated when the terminal elimination rate constant (λz) was not estimable.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=8 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=3 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=7 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=29 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=5 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=3 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=2 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Apparent Terminal Phase Half-life (t½) of Enasidenib After a Single Oral Dose on Day -3
|
36.8 hours
Geometric Coefficient of Variation 57.3
|
33.2 hours
Geometric Coefficient of Variation 124.6
|
52.6 hours
Geometric Coefficient of Variation 109.5
|
65.9 hours
Geometric Coefficient of Variation 86.5
|
96.2 hours
Geometric Coefficient of Variation 60.1
|
73.8 hours
Geometric Coefficient of Variation 18.8
|
91.3 hours
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=4 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=102 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=5 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of Enasidenib After Multiple Oral Doses
|
81775 ng*h/mL
Geometric Coefficient of Variation 35.2
|
34338 ng*h/mL
Geometric Coefficient of Variation 62.5
|
103364 ng*h/mL
Geometric Coefficient of Variation 34.1
|
135649 ng*h/mL
Geometric Coefficient of Variation 31.4
|
162308 ng*h/mL
Geometric Coefficient of Variation 18.0
|
43407 ng*h/mL
Geometric Coefficient of Variation 106.5
|
44360 ng*h/mL
Geometric Coefficient of Variation 57.2
|
83444 ng*h/mL
Geometric Coefficient of Variation 48.9
|
101462 ng*h/mL
Geometric Coefficient of Variation 37.7
|
108404 ng*h/mL
Geometric Coefficient of Variation 53.1
|
105098 ng*h/mL
Geometric Coefficient of Variation 40.9
|
181186 ng*h/mL
Geometric Coefficient of Variation 21.5
|
219708 ng*h/mL
Geometric Coefficient of Variation 14.6
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 10 hours post-dose (AUC0-10) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=4 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=4 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=94 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=5 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=3 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=2 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to 10 Hours Postdose (AUC0-10) of Enasidenib After Multiple Oral Doses
|
99954 ng*h/mL
Geometric Coefficient of Variation 35.1
|
41108 ng*h/mL
Geometric Coefficient of Variation 63.2
|
126765 ng*h/mL
Geometric Coefficient of Variation 34.6
|
174409 ng*h/mL
Geometric Coefficient of Variation 32.0
|
200661 ng*h/mL
Geometric Coefficient of Variation 18.9
|
61226 ng*h/mL
Geometric Coefficient of Variation 117.0
|
53067 ng*h/mL
Geometric Coefficient of Variation 50.1
|
104824 ng*h/mL
Geometric Coefficient of Variation 47.6
|
126237 ng*h/mL
Geometric Coefficient of Variation 37.8
|
132718 ng*h/mL
Geometric Coefficient of Variation 52.0
|
131523 ng*h/mL
Geometric Coefficient of Variation 43.0
|
199749 ng*h/mL
Geometric Coefficient of Variation 24.0
|
269750 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=4 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=107 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=5 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Enasidenib After Multiple Oral Doses
|
99954 ng*h/mL
Geometric Coefficient of Variation 35.1
|
41108 ng*h/mL
Geometric Coefficient of Variation 63.2
|
126765 ng*h/mL
Geometric Coefficient of Variation 34.6
|
174409 ng*h/mL
Geometric Coefficient of Variation 32.0
|
200661 ng*h/mL
Geometric Coefficient of Variation 18.9
|
51273 ng*h/mL
Geometric Coefficient of Variation 111.1
|
53067 ng*h/mL
Geometric Coefficient of Variation 50.1
|
100119 ng*h/mL
Geometric Coefficient of Variation 49.7
|
126237 ng*h/mL
Geometric Coefficient of Variation 37.8
|
132718 ng*h/mL
Geometric Coefficient of Variation 52.0
|
131523 ng*h/mL
Geometric Coefficient of Variation 43.0
|
202702 ng*h/mL
Geometric Coefficient of Variation 17.8
|
256155 ng*h/mL
Geometric Coefficient of Variation 16.0
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=4 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=107 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=5 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Concentration (Cmax) of Enasidenib After Multiple Oral Doses
|
12538 ng/mL
Geometric Coefficient of Variation 39.2
|
5300 ng/mL
Geometric Coefficient of Variation 71.9
|
15860 ng/mL
Geometric Coefficient of Variation 34.5
|
23962 ng/mL
Geometric Coefficient of Variation 25.3
|
26715 ng/mL
Geometric Coefficient of Variation 24.7
|
6543 ng/mL
Geometric Coefficient of Variation 124.9
|
6922 ng/mL
Geometric Coefficient of Variation 64.2
|
13012 ng/mL
Geometric Coefficient of Variation 46.5
|
15734 ng/mL
Geometric Coefficient of Variation 38.6
|
17990 ng/mL
Geometric Coefficient of Variation 64.0
|
18505 ng/mL
Geometric Coefficient of Variation 42.4
|
28049 ng/mL
Geometric Coefficient of Variation 23.4
|
35269 ng/mL
Geometric Coefficient of Variation 10.7
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=4 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=107 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=5 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Maximum Concentration (Tmax) of Enasidenib After Multiple Oral Doses
|
2.00 hours
Interval 0.5 to 9.83
|
0.50 hours
Interval 0.0 to 3.92
|
0.50 hours
Interval 0.0 to 1.0
|
4.47 hours
Interval 0.48 to 9.83
|
1.54 hours
Interval 1.0 to 9.83
|
3.02 hours
Interval 0.0 to 10.0
|
4.04 hours
Interval 1.0 to 10.08
|
1.02 hours
Interval 0.0 to 10.0
|
2.13 hours
Interval 0.7 to 9.83
|
1.02 hours
Interval 0.0 to 8.0
|
5.98 hours
Interval 0.0 to 9.95
|
4.08 hours
Interval 0.97 to 6.0
|
2.00 hours
Interval 1.95 to 3.0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, and 8 hours post-dose.Population: Participants who received enasidenib on Cycle 1 Day 1 or Cycle 2 Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of enasidenib was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=89 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Area Under the Plasma Concentration Time Curve From Time Zero to 8 Hours Postdose (AUC0-8) of Enasidenib After Single and Multiple Oral Doses
Cycle 1, Day 1
|
—
|
8134 ng*h/mL
Geometric Coefficient of Variation 49.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Plasma Concentration Time Curve From Time Zero to 8 Hours Postdose (AUC0-8) of Enasidenib After Single and Multiple Oral Doses
Cycle 2, Day 1
|
—
|
86505 ng*h/mL
Geometric Coefficient of Variation 44.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1 Day 1 or Cycle 2 Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2 Day 1.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=58 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours Postdose (AUC 0-24) of Enasidenib After Single and Multiple Oral Doses
Cycle 1, Day 1
|
—
|
27889 ng*h/mL
Geometric Coefficient of Variation 46.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours Postdose (AUC 0-24) of Enasidenib After Single and Multiple Oral Doses
Cycle 2, Day 1
|
—
|
263131 ng*h/mL
Geometric Coefficient of Variation 42.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1 Day 1 or Cycle 2 Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2 Day 1.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=92 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Enasidenib After Single and Multiple Oral Doses
Cycle 1, Day 1
|
—
|
17447 ng*h/mL
Geometric Coefficient of Variation 88.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Enasidenib After Single and Multiple Oral Doses
Cycle 2, Day 1
|
—
|
185566 ng*h/mL
Geometric Coefficient of Variation 75.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1 Day 1 or Cycle 2 Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2 Day 1.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=92 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Maximum Concentration (Cmax) of Enasidenib After Single and Multiple Oral Doses
Cycle 1, Day 1
|
—
|
1522 ng/mL
Geometric Coefficient of Variation 45.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Concentration (Cmax) of Enasidenib After Single and Multiple Oral Doses
Cycle 2, Day 1
|
—
|
13126 ng/mL
Geometric Coefficient of Variation 42.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1 Day 1 or Cycle 2 Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2 Day 1.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=92 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Maximum Concentration (Tmax) of Enasidenib After Single and Multiple Oral Doses
Cycle 1, Day 1
|
—
|
4.04 hours
Interval 1.83 to 27.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Maximum Concentration (Tmax) of Enasidenib After Single and Multiple Oral Doses
Cycle 2, Day 1
|
—
|
2.08 hours
Interval 0.0 to 23.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1 Day 1 or Cycle 2 Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2 Day 1. t1/2 was not calculated when the terminal elimination rate constant (λz) was not estimable.
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=19 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Apparent Terminal Phase Half-life (t1/2) of Enasidenib After Single and Multiple Oral Doses
Cycle 1, Day 1
|
—
|
38.3 hours
Geometric Coefficient of Variation 81.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation and Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to hour 8 post-dose (AUC 0-8) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=55 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of AGI-16903 After a Single Oral Dose of Enasidenib on Day -3
|
187 ng*h/mL
Geometric Coefficient of Variation 134.4
|
122 ng*h/mL
Geometric Coefficient of Variation 83.6
|
276 ng*h/mL
Geometric Coefficient of Variation 80.6
|
276 ng*h/mL
Geometric Coefficient of Variation 104.1
|
558 ng*h/mL
Geometric Coefficient of Variation 70.3
|
530 ng*h/mL
Geometric Coefficient of Variation 91.1
|
526 ng*h/mL
Geometric Coefficient of Variation 58.8
|
384 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
1470 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 10 hours post-dose (AUC0-10) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=54 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to 10 Hours Postdose (AUC0-10) of AGI-16903 After a Single Oral Dose of Enasidenib on Day -3
|
258 ng*h/mL
Geometric Coefficient of Variation 135.1
|
162 ng*h/mL
Geometric Coefficient of Variation 80.4
|
383 ng*h/mL
Geometric Coefficient of Variation 72.3
|
379 ng*h/mL
Geometric Coefficient of Variation 99.3
|
735 ng*h/mL
Geometric Coefficient of Variation 65.1
|
716 ng*h/mL
Geometric Coefficient of Variation 86.8
|
757 ng*h/mL
Geometric Coefficient of Variation 57.5
|
548 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
1893 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=53 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to 24 Hours Postdose (AUC0-24) of AGI-16903 After a Single Oral Dose of Enasidenib on Day -3
|
777 ng*h/mL
Geometric Coefficient of Variation 111.7
|
474 ng*h/mL
Geometric Coefficient of Variation 80.4
|
1238 ng*h/mL
Geometric Coefficient of Variation 54.4
|
1222 ng*h/mL
Geometric Coefficient of Variation 71.4
|
2128 ng*h/mL
Geometric Coefficient of Variation 54.2
|
2159 ng*h/mL
Geometric Coefficient of Variation 75.4
|
2477 ng*h/mL
Geometric Coefficient of Variation 51.5
|
2274 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 72 hours post-dose (AUC0-72) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=8 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=48 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=9 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=1 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to 72 Hours Postdose (AUC0-72) of AGI-16903 After a Single Oral Dose of Enasidenib on Day -3
|
2121 ng*h/mL
Geometric Coefficient of Variation 104.8
|
1403 ng*h/mL
Geometric Coefficient of Variation 93.7
|
3427 ng*h/mL
Geometric Coefficient of Variation 40.9
|
4283 ng*h/mL
Geometric Coefficient of Variation 58.0
|
7188 ng*h/mL
Geometric Coefficient of Variation 43.6
|
7634 ng*h/mL
Geometric Coefficient of Variation 66.2
|
10673 ng*h/mL
Geometric Coefficient of Variation 29.8
|
17591 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=55 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) of AGI-16903 After a Single Oral Dose of Enasidenib on Day -3
|
2101 ng*h/mL
Geometric Coefficient of Variation 86.2
|
1403 ng*h/mL
Geometric Coefficient of Variation 93.7
|
3560 ng*h/mL
Geometric Coefficient of Variation 40.0
|
3764 ng*h/mL
Geometric Coefficient of Variation 83.8
|
7188 ng*h/mL
Geometric Coefficient of Variation 43.6
|
7070 ng*h/mL
Geometric Coefficient of Variation 62.0
|
6531 ng*h/mL
Geometric Coefficient of Variation 93.9
|
8035 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
1893 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=55 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Concentration of AGI-16903 After a Single Oral Dose of Enasidenib on Day -3
|
47 ng/mL
Geometric Coefficient of Variation 68.3
|
29 ng/mL
Geometric Coefficient of Variation 89.3
|
74 ng/mL
Geometric Coefficient of Variation 52.3
|
79 ng/mL
Geometric Coefficient of Variation 60.6
|
126 ng/mL
Geometric Coefficient of Variation 39.4
|
138 ng/mL
Geometric Coefficient of Variation 47.4
|
151 ng/mL
Geometric Coefficient of Variation 52.4
|
188 ng/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
242 ng/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=55 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Maximum Concentration (Tmax) of AGI-16903 After a Single Oral Dose of Enasidenib on Day -3
|
10.00 hours
Interval 1.92 to 69.5
|
36.38 hours
Interval 3.0 to 70.42
|
10.00 hours
Interval 3.0 to 71.0
|
48.00 hours
Interval 3.0 to 74.42
|
24.12 hours
Interval 6.2 to 72.1
|
47.33 hours
Interval 1.98 to 72.82
|
48.10 hours
Interval 7.95 to 72.17
|
59.88 hours
Interval 48.25 to 71.5
|
6.17 hours
Interval 6.17 to 6.17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. t1/2 was not calculated when the terminal elimination rate constant (λz) was not estimable.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=4 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=1 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=2 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=7 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=1 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Apparent Terminal Phase Half-life (t½) of AGI-16903 After a Single Oral Dose of Enasidenib on Day -3
|
46.9 hours
Geometric Coefficient of Variation 125.7
|
18.9 hours
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
29.0 hours
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
69.2 hours
Geometric Coefficient of Variation 161.0
|
106.4 hours
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=2 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=102 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=3 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of AGI-16903 After Multiple Oral Doses of Enasidenib
|
7656 ng*h/mL
Geometric Coefficient of Variation 47.5
|
4028 ng*h/mL
Geometric Coefficient of Variation 82.9
|
7340 ng*h/mL
Geometric Coefficient of Variation 59.8
|
10655 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
16638 ng*h/mL
Geometric Coefficient of Variation 15.7
|
4395 ng*h/mL
Geometric Coefficient of Variation 125.7
|
3281 ng*h/mL
Geometric Coefficient of Variation 87.3
|
7645 ng*h/mL
Geometric Coefficient of Variation 42.7
|
10720 ng*h/mL
Geometric Coefficient of Variation 38.3
|
11579 ng*h/mL
Geometric Coefficient of Variation 47.5
|
9961 ng*h/mL
Geometric Coefficient of Variation 36.0
|
15888 ng*h/mL
Geometric Coefficient of Variation 35.4
|
20480 ng*h/mL
Geometric Coefficient of Variation 36.8
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 10 hours post-dose (AUC0-10) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=2 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=4 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=94 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=3 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=3 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=2 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to 10 Hours Postdose (AUC0-10) of AGI-16903 After Multiple Oral Doses of Enasidenib
|
9437 ng*h/mL
Geometric Coefficient of Variation 46.8
|
4830 ng*h/mL
Geometric Coefficient of Variation 82.9
|
9002 ng*h/mL
Geometric Coefficient of Variation 60.0
|
13463 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
20705 ng*h/mL
Geometric Coefficient of Variation 16.1
|
6502 ng*h/mL
Geometric Coefficient of Variation 132.7
|
3954 ng*h/mL
Geometric Coefficient of Variation 80.6
|
9502 ng*h/mL
Geometric Coefficient of Variation 42.0
|
13263 ng*h/mL
Geometric Coefficient of Variation 40.1
|
14303 ng*h/mL
Geometric Coefficient of Variation 47.2
|
12448 ng*h/mL
Geometric Coefficient of Variation 35.0
|
17963 ng*h/mL
Geometric Coefficient of Variation 18.7
|
22102 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=2 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=107 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=3 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) of AGI-16903 After Multiple Oral Doses of Enasidenib
|
9437 ng*h/mL
Geometric Coefficient of Variation 46.8
|
4830 ng*h/mL
Geometric Coefficient of Variation 82.9
|
9002 ng*h/mL
Geometric Coefficient of Variation 60.0
|
13463 ng*h/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
20705 ng*h/mL
Geometric Coefficient of Variation 16.1
|
5181 ng*h/mL
Geometric Coefficient of Variation 133.1
|
3954 ng*h/mL
Geometric Coefficient of Variation 80.6
|
9193 ng*h/mL
Geometric Coefficient of Variation 42.1
|
13263 ng*h/mL
Geometric Coefficient of Variation 40.1
|
14303 ng*h/mL
Geometric Coefficient of Variation 47.2
|
12448 ng*h/mL
Geometric Coefficient of Variation 35.0
|
17846 ng*h/mL
Geometric Coefficient of Variation 33.7
|
24187 ng*h/mL
Geometric Coefficient of Variation 24.4
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=2 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=107 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=3 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Concentration (Cmax) of AGI-16903 After Multiple Oral Doses of Enasidenib
|
1149 ng/mL
Geometric Coefficient of Variation 54.0
|
619 ng/mL
Geometric Coefficient of Variation 95.0
|
1096 ng/mL
Geometric Coefficient of Variation 62.8
|
1717 ng/mL
Geometric Coefficient of Variation NA
Percent coefficient of variation could not be calculated due to small sample size
|
2651 ng/mL
Geometric Coefficient of Variation 13.6
|
680 ng/mL
Geometric Coefficient of Variation 148.1
|
518 ng/mL
Geometric Coefficient of Variation 99.8
|
1199 ng/mL
Geometric Coefficient of Variation 42.3
|
1640 ng/mL
Geometric Coefficient of Variation 30.2
|
1817 ng/mL
Geometric Coefficient of Variation 55.0
|
1687 ng/mL
Geometric Coefficient of Variation 37.7
|
2415 ng/mL
Geometric Coefficient of Variation 33.2
|
3135 ng/mL
Geometric Coefficient of Variation 38.8
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=5 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=2 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=107 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=3 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=11 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Maximum Concentration (Tmax) of AGI-16903 After Multiple Oral Doses of Enasidenib
|
2.00 hours
Interval 1.0 to 10.0
|
1.50 hours
Interval 0.0 to 4.17
|
0.52 hours
Interval 0.33 to 7.97
|
1.48 hours
Interval 1.0 to 1.97
|
1.54 hours
Interval 1.0 to 8.0
|
2.92 hours
Interval 0.0 to 3.92
|
1.58 hours
Interval 1.0 to 6.08
|
1.00 hours
Interval 0.0 to 10.0
|
4.00 hours
Interval 2.0 to 9.83
|
1.00 hours
Interval 0.0 to 8.0
|
5.98 hours
Interval 0.0 to 9.95
|
2.98 hours
Interval 0.97 to 6.0
|
1.97 hours
Interval 1.95 to 10.0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, and 8 hours post-dose.Population: Participants who received enasidenib on Cycle 1, Day 1 or Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=88 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 1, Day 1
|
—
|
323 ng*h/mL
Geometric Coefficient of Variation 90.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 2, Day 1
|
—
|
7409 ng*h/mL
Geometric Coefficient of Variation 45.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1, Day 1 or Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=58 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: AUC From Time Zero to 24 Hours Postdose (AUC0-24) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 1, Day 1
|
—
|
1482 ng*h/mL
Geometric Coefficient of Variation 63.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: AUC From Time Zero to 24 Hours Postdose (AUC0-24) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 2, Day 1
|
—
|
23963 ng*h/mL
Geometric Coefficient of Variation 43.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1, Day 1 or Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=91 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 1, Day 1
|
—
|
829 ng*h/mL
Geometric Coefficient of Variation 138.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 2, Day 1
|
—
|
16593 ng*h/mL
Geometric Coefficient of Variation 81.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1, Day 1 or Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=91 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Maximum Concentration (Cmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 1, Day 1
|
—
|
72 ng/mL
Geometric Coefficient of Variation 80.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Concentration (Cmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 2, Day 1
|
—
|
1158 ng/mL
Geometric Coefficient of Variation 48.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1, Day 1 or Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=91 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Maximum Concentration (Tmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 1, Day 1
|
—
|
8.00 hours
Interval 2.0 to 29.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Maximum Concentration (Tmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 2, Day 1
|
—
|
2.12 hours
Interval 0.0 to 23.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Cycle 1, Day 1 or Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. T1/2 was not calculated when the terminal elimination rate constant (λz) was not estimable.
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Apparent Terminal Phase Half-life (t1/2) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib
Cycle 1, Day 1
|
—
|
32.2 hours
Geometric Coefficient of Variation 116.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, and 8 hours post-dose.Population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=165 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: AUC From Time Zero to 8 Hours Postdose (AUC0-8) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Day -3 / Cycle 1, Day 1
|
—
|
7506 ng*h/mL
Geometric Coefficient of Variation 62.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 and 2: AUC From Time Zero to 8 Hours Postdose (AUC0-8) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Cycle 2, Day 1
|
—
|
84600 ng*h/mL
Geometric Coefficient of Variation 47.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=114 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: AUC From Time Zero to 24 Hours Postdose (AUC0-24) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Cycle 2, Day 1
|
—
|
263131 ng*h/mL
Geometric Coefficient of Variation 42.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 and 2: AUC From Time Zero to 24 Hours Postdose (AUC0-24) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Day -3 / Cycle 1, Day 1
|
—
|
24631 ng*h/mL
Geometric Coefficient of Variation 52.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=176 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Maximum Concentration (Cmax) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Cycle 2, Day 1
|
—
|
13057 ng/mL
Geometric Coefficient of Variation 44.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 and 2: Maximum Concentration (Cmax) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Day -3 / Cycle 1, Day 1
|
—
|
1423 ng/mL
Geometric Coefficient of Variation 50.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=176 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Time to Maximum Concentration (Tmax) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Day -3 / Cycle 1, Day 1
|
—
|
4.00 hours
Interval 0.67 to 71.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 and 2: Time to Maximum Concentration (Tmax) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Cycle 2, Day 1
|
—
|
2.00 hours
Interval 0.0 to 23.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, and 8 hours post-dose.Population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=164 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Day -3 / Cycle 1, Day 1
|
—
|
304 ng*h/mL
Geometric Coefficient of Variation 96.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 and 2: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Cycle 2, Day 1
|
—
|
7555 ng*h/mL
Geometric Coefficient of Variation 43.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) was calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=111 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: AUC From Time Zero to 24 Hours Postdose (AUC0-24) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Day -3 / Cycle 1, Day 1
|
—
|
1352 ng*h/mL
Geometric Coefficient of Variation 68.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 and 2: AUC From Time Zero to 24 Hours Postdose (AUC0-24) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Cycle 2, Day 1
|
—
|
23963 ng*h/mL
Geometric Coefficient of Variation 43.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=175 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Maximum Concentration (Cmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Day -3 / Cycle 1, Day 1
|
—
|
75 ng/mL
Geometric Coefficient of Variation 73.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 and 2: Maximum Concentration (Cmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Cycle 2, Day 1
|
—
|
1183 ng/mL
Geometric Coefficient of Variation 44.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, 8, and 24 hours post-dose.Population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=175 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Time to Maximum Concentration (Tmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Day -3 / Cycle 1, Day 1
|
—
|
23.44 hours
Interval 2.0 to 74.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1 and 2: Time to Maximum Concentration (Tmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Cycle 2, Day 1
|
—
|
1.92 hours
Interval 0.0 to 23.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening visit, Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PD parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma 2-HG was measured using qualified LC-MS/MS in order to characterize the pharmacodynamic (PD) effects of enasidenib; the LLOQ was 30.0 ng/mL. Area under the effect concentration time curve from time point zero (predose) up to 10 hours postdose (AUEC0-10) was calculated using the linear trapezoid rule. Percent change from Baseline for AUEC0-10 was calculated as (AUEC0-10 minus \[Baseline\*Tlast\]) / (Baseline\*Tlast) \* 100, where Tlast corresponded to 10 hours and Baseline was equal to the average of the Screening and Day -3 (predose) 2-HG values. Data reported are the arithmetic mean and relative standard deviation expressed as a percentage.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=3 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=7 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=56 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=10 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=1 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Percent Change From Baseline for Area Under the Effect Concentration Time Curve From Time 0 to 10 Hours Postdose (%BAUEC0-10) of 2-hydroxyglutarate (2-HG) on Day -3
|
-13.55 percent change
Standard Deviation 71.3
|
2.43 percent change
Standard Deviation 1044.2
|
9.32 percent change
Standard Deviation 862.2
|
-7.28 percent change
Standard Deviation 270.8
|
-16.61 percent change
Standard Deviation 127.7
|
-11.92 percent change
Standard Deviation 95.3
|
-17.79 percent change
Standard Deviation 92.0
|
-8.92 percent change
Standard Deviation NA
Could not be calculated when N = 1
|
-16.14 percent change
Standard Deviation NA
Could not be calculated when N = 1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening visit, Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PD parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Dose Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma 2-HG was measured using qualified LC-MS/MS in order to characterize the pharmacodynamic (PD) effects of enasidenib; the LLOQ was 30.0 ng/mL. Minimum percent change from Baseline response value post-dose over 10 hours was calculated as: (minimum observed concentration post-dose over 10 hours \[Rmin\] - Baseline) / Baseline \* 100. Baseline was equal to the average of the Screening and Day -3 (predose) 2-HG values. Data reported are the arithmetic mean and relative standard deviation expressed as a percentage.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=57 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Minimum Percent Change From Baseline Response Value Post-dose Over 10 Hours (%BRmin) for 2-HG After a Single Oral Dose of Enasidenib on Day -3
|
-37.7 percent change
Standard Deviation 63.9
|
-36.9 percent change
Standard Deviation 43.9
|
-38.6 percent change
Standard Deviation 96.4
|
-47.5 percent change
Standard Deviation 53.1
|
-59.6 percent change
Standard Deviation 44.5
|
-56.9 percent change
Standard Deviation 37.5
|
-74.7 percent change
Standard Deviation 9.0
|
-31.5 percent change
Standard Deviation 38.6
|
-36.9 percent change
Standard Deviation NA
Could not be calculated for N = 1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3 prior to the single dose of enasidenib and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose.Population: Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PD parameters. Participants who received 2 doses on Day -3 or who received the incorrect dose were excluded. Participants in the Phase 1 Escalation BID and QD cohorts and Phase 1 Expansion cohorts were were grouped by dose for Day -3 analyses.
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). Plasma 2-HG was measured using qualified LC-MS/MS, the LLOQ was 30.0 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=9 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=4 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=9 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=57 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=8 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=11 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=4 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=2 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=1 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time of Minimum Observed Concentration Over 72 Hours Postdose (Tmin) of 2-HG After a Single Oral Dose of Enasidenib on Day -3
|
8.00 hours
Interval 1.13 to 72.42
|
35.78 hours
Interval 24.0 to 72.38
|
23.92 hours
Interval 2.92 to 71.42
|
48.00 hours
Interval 0.5 to 73.58
|
48.20 hours
Interval 1.0 to 72.3
|
48.70 hours
Interval 6.07 to 72.45
|
48.10 hours
Interval 24.42 to 72.17
|
30.79 hours
Interval 13.33 to 48.25
|
8.17 hours
Interval 8.17 to 8.17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15 and Cycle 2, Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
Plasma 2-HG was measured using qualified LC-MS/MS, the LLOQ was 30.0 ng/mL. Area under the effect concentration time curve from time point zero (predose) up to 10 hours postdose (AUEC0-10) was calculated using the linear trapezoid rule. Percent change from baseline for AUEC0-10 was calculated as: (AUEC0-10 minus \[Baseline\*Tlast\]) / (Baseline\*Tlast) \* 100, where Tlast corresponded to 10 hours and Baseline was equal to the average of the Screening and Day -3 (predose) 2-HG values. Data reported are the arithmetic mean and relative standard deviation expressed as a percentage.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=6 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=6 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=5 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=6 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=89 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=5 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=10 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=4 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=2 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Percent Change From Baseline for Area Under the Effect Concentration Time Curve From Time 0 to 10 Hours Postdose of 2-HG After Multiple Oral Doses of Enasidenib
Cycle 1, Day 15
|
-62.60 percent change
Standard Deviation 113.1
|
-62.18 percent change
Standard Deviation 48.9
|
-87.19 percent change
Standard Deviation 21.4
|
-84.24 percent change
Standard Deviation 14.2
|
-79.40 percent change
Standard Deviation 13.7
|
-58.76 percent change
Standard Deviation 44.9
|
-69.00 percent change
Standard Deviation 38.8
|
-64.23 percent change
Standard Deviation 80.3
|
-71.67 percent change
Standard Deviation 72.6
|
-79.34 percent change
Standard Deviation 34.1
|
-87.74 percent change
Standard Deviation 5.7
|
-62.89 percent change
Standard Deviation 48.8
|
2.54 percent change
Standard Deviation NA
Could not be calculated for N = 1
|
|
Phase 1: Percent Change From Baseline for Area Under the Effect Concentration Time Curve From Time 0 to 10 Hours Postdose of 2-HG After Multiple Oral Doses of Enasidenib
Cycle 2, Day 1
|
-35.49 percent change
Standard Deviation 430.9
|
-49.01 percent change
Standard Deviation 115.4
|
-64.63 percent change
Standard Deviation 74.7
|
-83.93 percent change
Standard Deviation 19.0
|
-78.07 percent change
Standard Deviation 17.2
|
-81.51 percent change
Standard Deviation 25.9
|
-66.41 percent change
Standard Deviation 70.5
|
-53.46 percent change
Standard Deviation 190.7
|
-37.70 percent change
Standard Deviation 317.5
|
-27.70 percent change
Standard Deviation 599.5
|
-87.88 percent change
Standard Deviation 9.4
|
-76.98 percent change
Standard Deviation 40.2
|
-82.28 percent change
Standard Deviation 24.9
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15 and Cycle 2, Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
Plasma 2-HG was measured using qualified LC-MS/MS, the LLOQ was 30.0 ng/mL. Minimum percent change from Baseline response value post-dose over 10 hours was calculated as: (minimum observed concentration post-dose over 10 hours \[Rmin\] - Baseline) / Baseline \* 100. Baseline was equal to the average of the Screening and Day -3 (predose) 2-HG values. Data reported are the arithmetic mean and relative standard deviation expressed as a percentage.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=6 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=6 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=6 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=7 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=102 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=6 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=12 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Minimum Percent Change From Baseline Response Value Post-dose Over 10 Hours (%BRmin) for 2-HG After Multiple Oral Doses of Enasidenib
Cycle 1, Day 15
|
-76.5 percent change
Standard Deviation 56.4
|
-69.0 percent change
Standard Deviation 42.0
|
-89.2 percent change
Standard Deviation 18.9
|
-88.6 percent change
Standard Deviation 12.3
|
-81.4 percent change
Standard Deviation 11.6
|
-63.3 percent change
Standard Deviation 40.7
|
-79.3 percent change
Standard Deviation 22.0
|
-71.0 percent change
Standard Deviation 57.1
|
-80.4 percent change
Standard Deviation 45.7
|
-86.0 percent change
Standard Deviation 25.3
|
-91.2 percent change
Standard Deviation 4.0
|
-71.3 percent change
Standard Deviation 31.5
|
-23.1 percent change
Standard Deviation NA
Could not be calculated for N = 1
|
|
Phase 1: Minimum Percent Change From Baseline Response Value Post-dose Over 10 Hours (%BRmin) for 2-HG After Multiple Oral Doses of Enasidenib
Cycle 2, Day 1
|
-54.5 percent change
Standard Deviation 192.9
|
-54.8 percent change
Standard Deviation 94.7
|
-68.9 percent change
Standard Deviation 63.3
|
-89.5 percent change
Standard Deviation 12.5
|
-80.7 percent change
Standard Deviation 14.5
|
-84.8 percent change
Standard Deviation 18.5
|
-70.6 percent change
Standard Deviation 61.8
|
-65.6 percent change
Standard Deviation 94.7
|
-47.2 percent change
Standard Deviation 224.0
|
-35.6 percent change
Standard Deviation 422.0
|
-89.8 percent change
Standard Deviation 8.0
|
-60.6 percent change
Standard Deviation 83.8
|
-53.5 percent change
Standard Deviation 120.5
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15 and Cycle 2, Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.Population: Participants who received enasidenib on Cycle 1, Day 15 or Cycle 2, Day 1 with sufficient data to determine PD parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
Plasma 2-HG was measured using qualified LC-MS/MS, the LLOQ was 30.0 ng/mL.
Outcome measures
| Measure |
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
n=7 Participants
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=6 Participants
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=6 Participants
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=6 Participants
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=4 Participants
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=5 Participants
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=7 Participants
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=102 Participants
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=6 Participants
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=12 Participants
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=7 Participants
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 Participants
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=3 Participants
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time of Minimum Observed Concentration Over 10 Hours Postdose (Tmin) of 2-HG After Multiple Oral Doses of Enasidenib
Cycle 1, Day 15
|
5.90 hours
Interval 1.0 to 10.0
|
4.00 hours
Interval 2.15 to 10.0
|
3.03 hours
Interval 0.5 to 10.0
|
4.44 hours
Interval 1.1 to 10.0
|
1.00 hours
Interval 0.5 to 2.0
|
3.00 hours
Interval 0.5 to 6.05
|
5.85 hours
Interval 0.42 to 10.0
|
3.10 hours
Interval 0.35 to 10.0
|
6.50 hours
Interval 1.0 to 10.02
|
1.53 hours
Interval 0.5 to 8.0
|
7.08 hours
Interval 3.0 to 10.0
|
4.00 hours
Interval 0.5 to 8.07
|
2.87 hours
Interval 2.87 to 2.87
|
|
Phase 1: Time of Minimum Observed Concentration Over 10 Hours Postdose (Tmin) of 2-HG After Multiple Oral Doses of Enasidenib
Cycle 2, Day 1
|
3.00 hours
Interval 1.0 to 10.0
|
0.98 hours
Interval 0.42 to 4.0
|
6.17 hours
Interval 2.0 to 8.08
|
6.00 hours
Interval 0.97 to 6.0
|
2.00 hours
Interval 0.5 to 9.97
|
2.95 hours
Interval 0.48 to 10.08
|
6.96 hours
Interval 2.0 to 10.02
|
3.65 hours
Interval 0.3 to 10.32
|
4.00 hours
Interval 0.97 to 10.03
|
5.95 hours
Interval 1.0 to 7.93
|
7.92 hours
Interval 0.98 to 9.87
|
6.00 hours
Interval 1.0 to 9.83
|
2.00 hours
Interval 0.53 to 4.0
|
Adverse Events
Phase 2: Enasidenib 100 mg QD
Serious events: 86 serious events
Other events: 106 other events
Deaths: 83 deaths
Phase 1 Dose Escalation: Enasidenib 30 mg BID
Serious events: 6 serious events
Other events: 7 other events
Deaths: 6 deaths
Phase 1 Dose Escalation: Enasidenib 50 mg BID
Serious events: 6 serious events
Other events: 7 other events
Deaths: 3 deaths
Phase 1 Dose Escalation: Enasidenib 75 mg BID
Serious events: 6 serious events
Other events: 7 other events
Deaths: 7 deaths
Phase 1 Dose Escalation: Enasidenib 100 mg BID
Serious events: 7 serious events
Other events: 8 other events
Deaths: 5 deaths
Phase 1 Dose Escalation: Enasidenib 150 mg BID
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
Phase 1 Dose Escalation: Enasidenib 50 mg QD
Serious events: 9 serious events
Other events: 8 other events
Deaths: 8 deaths
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Serious events: 5 serious events
Other events: 7 other events
Deaths: 6 deaths
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Serious events: 19 serious events
Other events: 22 other events
Deaths: 20 deaths
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Serious events: 11 serious events
Other events: 14 other events
Deaths: 7 deaths
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Serious events: 7 serious events
Other events: 9 other events
Deaths: 8 deaths
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Serious events: 5 serious events
Other events: 5 other events
Deaths: 3 deaths
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Serious events: 6 serious events
Other events: 7 other events
Deaths: 5 deaths
Ph1Exp Arm 1 (R/R AML Age >=60 or R From BMT)
Serious events: 43 serious events
Other events: 50 other events
Deaths: 40 deaths
Ph1Exp Arm 2 (R/R AML Excluding Arm 1)
Serious events: 18 serious events
Other events: 23 other events
Deaths: 15 deaths
Ph1Exp Arm 4 (Not Eligible for Arms 1 to 3)
Serious events: 20 serious events
Other events: 27 other events
Deaths: 17 deaths
Ph1Exp Arm 3 (Untrt AML Age >=60 No SOC Chemo)
Serious events: 20 serious events
Other events: 25 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Phase 2: Enasidenib 100 mg QD
n=106 participants at risk
Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=7 participants at risk
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg BID
n=7 participants at risk
Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=7 participants at risk
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=8 participants at risk
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=5 participants at risk
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=9 participants at risk
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=7 participants at risk
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=22 participants at risk
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=6 participants at risk
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=14 participants at risk
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=9 participants at risk
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 participants at risk
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=7 participants at risk
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Ph1Exp Arm 1 (R/R AML Age >=60 or R From BMT)
n=50 participants at risk
Participants ≥ 60 years old with relapsed, refractory (R/R) AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Ph1Exp Arm 2 (R/R AML Excluding Arm 1)
n=24 participants at risk
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Ph1Exp Arm 4 (Not Eligible for Arms 1 to 3)
n=27 participants at risk
Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Ph1Exp Arm 3 (Untrt AML Age >=60 No SOC Chemo)
n=25 participants at risk
Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
INTRACRANIAL HAEMATOMA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
PROTHROMBIN TIME PROLONGED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
TROPONIN I INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
TROPONIN INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERVOLAEMIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
IRON OVERLOAD
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
6.6%
7/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATIC DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL SQUAMOUS CELL CARCINOMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHLOROMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFERENTIATION SYNDROME
|
6.6%
7/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.2%
4/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOPROLIFERATIVE DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
FACIAL PARALYSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
HEADACHE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
NERVE COMPRESSION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
SCIATICA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
MANIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
AZOTAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
PRERENAL FAILURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
SUBCAPSULAR RENAL HAEMATOMA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
PENILE PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
SCROTAL OEDEMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL NECROSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL INFLAMMATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
NEUTROPHILIC DERMATOSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
PYODERMA GANGRENOSUM
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Surgical and medical procedures
HAEMORRHAGE PROPHYLAXIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Surgical and medical procedures
INCISIONAL DRAINAGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
HAEMATOMA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
HYPOTENSION
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
LYMPHOEDEMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
BONE MARROW FAILURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
33.0%
35/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
66.7%
6/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.9%
9/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
32.0%
16/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.8%
5/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
HAEMOLYSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
12.3%
13/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
21.4%
3/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
LEUKOSTASIS SYNDROME
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
SPLEEN DISORDER
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
SPLENIC INFARCTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
SPLENIC VEIN THROMBOSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
ANGINA PECTORIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
CARDIAC ARREST
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
CARDIAC VALVE DISEASE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
DIASTOLIC DYSFUNCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
PERICARDITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Congenital, familial and genetic disorders
APLASIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Congenital, familial and genetic disorders
ARTERIOVENOUS MALFORMATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
APPENDIX DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
COLITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ENTEROVESICAL FISTULA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GASTROINTESTINAL OBSTRUCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
NAUSEA
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
NEUTROPENIC COLITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
OEDEMA MOUTH
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
PERIODONTAL DISEASE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
VOMITING
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
10.0%
5/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
ASTHENIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CHEST PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CHILLS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
FACIAL PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
FATIGUE
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
HYPOTHERMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
LOCALISED OEDEMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
MALAISE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
MASS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
PYREXIA
|
10.4%
11/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
SECRETION DISCHARGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
ACUTE HEPATIC FAILURE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
HEPATIC CYTOLYSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
HYPERTRANSAMINASAEMIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Immune system disorders
GRAFT VERSUS HOST DISEASE
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Immune system disorders
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CELLULITIS
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ABSCESS BACTERIAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ANORECTAL INFECTION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
APPENDICITIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ASPERGILLUS INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
BACTERAEMIA
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CYSTITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
DIVERTICULITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ENCEPHALITIS VIRAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ENTEROCOCCAL INFECTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
MICROCOCCUS INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ENTEROCOCCAL SEPSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GASTROENTERITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GINGIVITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GRANULICATELLA INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GROIN ABSCESS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
KLEBSIELLA SEPSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
LARGE INTESTINE INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
LYMPH GLAND INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PERITONITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PNEUMONIA
|
24.5%
26/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
4/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
26.0%
13/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
41.7%
10/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
6/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
24.0%
6/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PNEUMONIA ASPIRATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PSOAS ABSCESS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SCROTAL ABSCESS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SCROTAL CELLULITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SEPSIS
|
12.3%
13/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.5%
3/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
44.4%
4/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
8/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SEPTIC SHOCK
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SINUSITIS
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SINUSITIS BACTERIAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SINUSITIS FUNGAL
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SKIN INFECTION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
URETHRAL ABSCESS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
VIRAL MYOCARDITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
COMPRESSION FRACTURE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
WOUND HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD CREATINE INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD CULTURE POSITIVE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD LACTIC ACID INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD PRESSURE SYSTOLIC DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
MENSTRUATION NORMAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
OCCULT BLOOD POSITIVE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
Other adverse events
| Measure |
Phase 2: Enasidenib 100 mg QD
n=106 participants at risk
Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 30 mg BID
n=7 participants at risk
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg BID
n=7 participants at risk
Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg BID
n=7 participants at risk
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg BID
n=8 participants at risk
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg BID
n=5 participants at risk
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 50 mg QD
n=9 participants at risk
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 75 mg QD
n=7 participants at risk
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 100 mg QD
n=22 participants at risk
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 150 mg QD
n=6 participants at risk
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 200 mg QD
n=14 participants at risk
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 300 mg QD
n=9 participants at risk
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 450 mg QD
n=5 participants at risk
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Phase 1 Dose Escalation: Enasidenib 650 mg QD
n=7 participants at risk
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Ph1Exp Arm 1 (R/R AML Age >=60 or R From BMT)
n=50 participants at risk
Participants ≥ 60 years old with relapsed, refractory (R/R) AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Ph1Exp Arm 2 (R/R AML Excluding Arm 1)
n=24 participants at risk
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Ph1Exp Arm 4 (Not Eligible for Arms 1 to 3)
n=27 participants at risk
Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
Ph1Exp Arm 3 (Untrt AML Age >=60 No SOC Chemo)
n=25 participants at risk
Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GLOSSITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
6.6%
7/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ILEUS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMATOMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
LIP DISORDER
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
NAUSEA
|
54.7%
58/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
71.4%
5/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
4/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
55.6%
5/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
31.8%
7/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
3/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
64.3%
9/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
44.4%
4/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.0%
21/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
54.2%
13/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
44.4%
12/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
36.0%
9/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ORAL BLOOD BLISTER
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ORAL DISORDER
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CHILLS
|
6.6%
7/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ORAL PAIN
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
POOR DENTAL CONDITION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
PROCTALGIA
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
RETCHING
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CATHETER SITE EROSION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
SALIVARY HYPERSECRETION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
STOMATITIS
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
TONGUE COATED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
TOOTHACHE
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
VOMITING
|
31.1%
33/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.5%
3/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
66.7%
4/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
6/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
20/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
8/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.0%
7/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
ASTHENIA
|
13.2%
14/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
71.4%
5/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.7%
5/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
21.4%
3/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
10/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
AXILLARY PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CATHETER SITE IRRITATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CATHETER SITE PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CHEST DISCOMFORT
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CHEST PAIN
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
CYST
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
FATIGUE
|
45.3%
48/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.5%
3/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
60.0%
3/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
31.8%
7/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
6/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
60.0%
3/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
36.0%
18/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
12/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.0%
10/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
48.0%
12/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
HERNIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
IMPAIRED HEALING
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
INFUSION SITE ERYTHEMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
INFUSION SITE INDURATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
LOCALISED OEDEMA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
MALAISE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
MASS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
MUCOSAL DISCOLOURATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
MUCOSAL INFLAMMATION
|
9.4%
10/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.7%
5/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.0%
7/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
NODULE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
OEDEMA
|
9.4%
10/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
OEDEMA PERIPHERAL
|
32.1%
34/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
4/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
3/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
35.7%
5/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
34.0%
17/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.5%
5/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
44.0%
11/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
PAIN
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
PERIPHERAL SWELLING
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
PRE-EXISTING CONDITION IMPROVED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
PYREXIA
|
23.6%
25/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
71.4%
5/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
31.8%
7/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
6/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
24.0%
12/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
6/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
6/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
SWELLING
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
SWELLING FACE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
TEMPERATURE INTOLERANCE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
HEPATOSPLENOMEGALY
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
General disorders
XEROSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
CHOLESTASIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
HEPATIC CYTOLYSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
8.5%
9/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Hepatobiliary disorders
OCULAR ICTERUS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Immune system disorders
GRAFT VERSUS HOST DISEASE
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
BACTERAEMIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
BACTERIAL COLITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
BONE ABSCESS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CANDIDA INFECTION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CELLULITIS
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CONJUNCTIVITIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
CONJUNCTIVITIS BACTERIAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
37.7%
40/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
27.3%
6/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
4/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.0%
11/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
6/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
44.0%
11/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
BLOOD LOSS ANAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
8.5%
9/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.7%
5/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
14.2%
15/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.7%
5/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
6/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.2%
4/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
9.4%
10/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
23.6%
25/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.2%
4/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
21.4%
3/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.0%
7/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.8%
5/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.9%
7/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
4/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIC PURPURA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
ACUTE LEFT VENTRICULAR FAILURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK RIGHT
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
CARDIAC VALVE DISEASE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
DIASTOLIC DYSFUNCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
PALPITATIONS
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
SYSTOLIC DYSFUNCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
TACHYCARDIA
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Congenital, familial and genetic disorders
APLASIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Congenital, familial and genetic disorders
GILBERT'S SYNDROME
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Ear and labyrinth disorders
EAR CONGESTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Ear and labyrinth disorders
EAR DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Ear and labyrinth disorders
EXCESSIVE CERUMEN PRODUCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Ear and labyrinth disorders
TINNITUS
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Ear and labyrinth disorders
VERTIGO
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Endocrine disorders
ADRENAL HAEMATOMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Endocrine disorders
ADRENAL MASS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
CATARACT
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
CHALAZION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
DIPLOPIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
DRY EYE
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
EYE DISCHARGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
EYE PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
EYE SWELLING
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
LACRIMATION INCREASED
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
ORBITAL HAEMATOMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
VISION BLURRED
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
12.3%
13/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
21.4%
3/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
10.0%
5/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
5/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.2%
4/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ANAL INCONTINENCE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ANOGENITAL DYSPLASIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
CHRONIC GASTRITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
COLITIS
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.5%
27/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
66.7%
6/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.2%
4/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
4/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
32.0%
16/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
29.2%
7/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.5%
5/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
10/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
DIARRHOEA
|
39.6%
42/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
4/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
55.6%
5/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
45.5%
10/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
3/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
7/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
80.0%
4/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
20/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
6/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.7%
11/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.0%
7/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
DRY MOUTH
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
DUODENOGASTRIC REFLUX
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.2%
4/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
10.0%
5/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
10.0%
5/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
FLATULENCE
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GASTRITIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GASTROINTESTINAL ANGIECTASIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.2%
4/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
21.4%
3/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GINGIVAL HYPERTROPHY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
14.2%
15/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.5%
5/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
4/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
21.7%
23/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.5%
3/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
60.0%
3/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.9%
9/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
66.7%
4/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
8/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
80.0%
4/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
20/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
8/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
29.6%
8/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
32.0%
8/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD BILIRUBIN UNCONJUGATED INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD CREATINE INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD CREATININE INCREASED
|
12.3%
13/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
5/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD FIBRINOGEN DECREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD PRESSURE DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD UREA INCREASED
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BLOOD URIC ACID INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
BRAIN NATRIURETIC PEPTIDE INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
CARBON DIOXIDE DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
EJECTION FRACTION DECREASED
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
EPSTEIN-BARR VIRUS ANTIBODY POSITIVE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
PROTHROMBIN LEVEL DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
HUMAN METAPNEUMOVIRUS TEST POSITIVE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
IMMUNOGLOBULINS DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
PROTHROMBIN TIME PROLONGED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.7%
5/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
60.0%
3/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
MAMMOGRAM ABNORMAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
MYOCARDIAL NECROSIS MARKER INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
4/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
PLATELET COUNT DECREASED
|
10.4%
11/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
5/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
PLATELET COUNT INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
PROTEIN TOTAL INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
URINE OUTPUT DECREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
WEIGHT DECREASED
|
11.3%
12/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
60.0%
3/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
24.0%
12/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
WEIGHT INCREASED
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
CELL DEATH
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
20.8%
22/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.5%
3/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.9%
9/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
35.7%
5/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
80.0%
4/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
48.0%
24/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.5%
9/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
9/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
10/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
12.3%
13/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERLIPASAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.7%
5/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
10.0%
5/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
14.2%
15/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
24.0%
12/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
6/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
29.6%
8/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
4/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
6.6%
7/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
16.0%
17/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.5%
3/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.7%
5/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.0%
9/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.8%
5/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
5/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
26.4%
28/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
27.3%
6/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
21.4%
3/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
44.4%
4/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
26.0%
13/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.5%
9/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.9%
7/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
32.0%
8/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
18.9%
20/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
21.4%
3/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
8/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.9%
7/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
24.0%
6/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
5/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOPHAGIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
11.3%
12/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
4/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOPROTEINAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
STEROID DIABETES
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
21.7%
23/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
4/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.7%
5/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
21.4%
3/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
8/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.9%
7/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
17.0%
18/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
50.0%
4/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
60.0%
3/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
4/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
CHONDROCALCINOSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
CHONDROPATHY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
JOINT RANGE OF MOTION DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
11.3%
12/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
HEMIPARESIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
27.3%
6/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
OSTEITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
14.2%
15/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
57.1%
4/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.2%
4/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
TENDON PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFERENTIATION SYNDROME
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA OF SKIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
VULVAL CANCER STAGE 0
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
AGEUSIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
DIZZINESS
|
13.2%
14/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.7%
5/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.0%
9/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.0%
7/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
DYSGEUSIA
|
10.4%
11/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.0%
7/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
HEADACHE
|
25.5%
27/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
27.3%
6/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
4/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.0%
9/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
6/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
18.5%
5/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
4/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
HYPERAESTHESIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
LETHARGY
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
PARAESTHESIA
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
10.0%
5/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
PAROSMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
10.4%
11/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
SEIZURE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
SINUS HEADACHE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
TASTE DISORDER
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
TOXIC ENCEPHALOPATHY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Nervous system disorders
TREMOR
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
ADJUSTMENT DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
ADJUSTMENT DISORDER WITH DEPRESSED MOOD
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
AGITATION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
ANGER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
ANXIETY
|
14.2%
15/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
4/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
10.4%
11/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
DELIRIUM
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
DEPRESSION
|
8.5%
9/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.5%
3/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
8/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
HALLUCINATION
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
INSOMNIA
|
18.9%
20/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.8%
5/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
IRRITABILITY
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
LIBIDO DECREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
PSYCHOMOTOR RETARDATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Psychiatric disorders
TOBACCO WITHDRAWAL SYMPTOMS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
9.4%
10/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
CHROMATURIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
DYSURIA
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
HAEMATURIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
POLLAKIURIA
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
POLYURIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
RENAL FAILURE
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
RENAL TUBULAR DYSFUNCTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
URETHRITIS NONINFECTIVE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
GENITAL LESION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
SCROTAL OEDEMA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
SCROTAL PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Reproductive system and breast disorders
VULVAL DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.0%
35/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
71.4%
5/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
44.4%
4/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
36.4%
8/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
66.7%
4/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
35.7%
5/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
32.0%
16/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
48.1%
13/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.0%
4/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
34.9%
37/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
55.6%
5/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
36.4%
8/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
30.0%
15/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
37.0%
10/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
10/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
19.8%
21/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
21.4%
3/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
42.9%
3/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
5/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
8.5%
9/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PLAQUE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
5.7%
6/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY GRANULOMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
RHONCHI
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS PAIN
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
BLOOD BLISTER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
CAPILLARITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS EXFOLIATIVE GENERALISED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.6%
7/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
HYPERTRICHOSIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
NAIL RIDGING
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
PAPULE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
6.6%
7/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
9.4%
10/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
4/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
RASH
|
10.4%
11/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
10/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
9/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
14.2%
15/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
RASH VESICULAR
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SKIN INDURATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
2/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
4/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SKIN MASS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
SOLAR LENTIGO
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
EMBOLISM
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
HAEMATOMA
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
HOT FLUSH
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
HYPERTENSION
|
10.4%
11/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
HYPOTENSION
|
11.3%
12/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
26.0%
13/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
LYMPHOCELE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
PALLOR
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
SCALP HAEMATOMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Vascular disorders
VARICOSE VEIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PNEUMONIA
|
14.2%
15/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
25.0%
2/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.0%
7/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
4/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GASTROINTESTINAL FUNGAL INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GASTROINTESTINAL VIRAL INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GENITAL HERPES
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GENITAL INFECTION FUNGAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
GINGIVITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
HAEMORRHOID INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
INCISION SITE CELLULITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
INFECTION
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
INFLUENZA
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
KLEBSIELLA BACTERAEMIA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
MUCOSAL INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
NAIL BED INFECTION BACTERIAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
ORAL HERPES
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PARONYCHIA
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
PULPITIS DENTAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
RASH PUSTULAR
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
RHINITIS
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SEPSIS
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SINUSITIS
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SINUSITIS FUNGAL
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
SKIN INFECTION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
STENOTROPHOMONAS INFECTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
TOOTH INFECTION
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
22.2%
2/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
6/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.8%
4/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.7%
5/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.0%
7/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.0%
2/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
URINARY TRACT INFECTION FUNGAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
VAGINAL INFECTION
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
VIRAL RHINITIS
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
ANIMAL SCRATCH
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
7.5%
8/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
EYE CONTUSION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
FALL
|
10.4%
11/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
1/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
40.0%
2/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
33.3%
3/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
2/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.0%
7/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.4%
2/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
5/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.5%
1/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
PERIORBITAL HAEMATOMA
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL DISCHARGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
PROCEDURAL HAEMORRHAGE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
1.9%
2/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
2/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
8.3%
2/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
REACTIVE GASTROPATHY
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
3.7%
1/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
STRESS FRACTURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
2.8%
3/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
2.0%
1/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Injury, poisoning and procedural complications
WOUND
|
0.94%
1/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.2%
1/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
3.8%
4/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
12.3%
13/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
14.3%
1/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
13.6%
3/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
7.1%
1/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
28.6%
2/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
10.0%
5/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.5%
3/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
12.0%
3/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
|
Investigations
AMYLASE INCREASED
|
0.00%
0/106 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/8 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
9.1%
2/22 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
16.7%
1/6 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/14 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
1/9 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
20.0%
1/5 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/7 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
6.0%
3/50 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
0.00%
0/24 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
11.1%
3/27 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
4.0%
1/25 • All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER