Trial Outcomes & Findings for Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (NCT NCT02397096)
NCT ID: NCT02397096
Last Updated: 2024-11-20
Results Overview
The percentage of participants in each arm achieving HIV-1 RNA levels \<50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
673 participants
Primary outcome timeframe
Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Results posted on
2024-11-20
Participant Flow
Out of 852 participants screened, 673 were randomized to study treatment, and 670 were treated. There were 122 global study sites utilized.
Participant milestones
| Measure |
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Day 1 to Week 24
STARTED
|
450
|
223
|
|
Day 1 to Week 24
Treated
|
447
|
223
|
|
Day 1 to Week 24
COMPLETED
|
427
|
209
|
|
Day 1 to Week 24
NOT COMPLETED
|
23
|
14
|
|
Week 24 to Week 48
STARTED
|
427
|
209
|
|
Week 24 to Week 48
COMPLETED
|
407
|
202
|
|
Week 24 to Week 48
NOT COMPLETED
|
20
|
7
|
|
Study Extension 1
STARTED
|
398
|
202
|
|
Study Extension 1
COMPLETED
|
357
|
179
|
|
Study Extension 1
NOT COMPLETED
|
41
|
23
|
|
Study Extension 2
STARTED
|
303
|
154
|
|
Study Extension 2
COMPLETED
|
129
|
78
|
|
Study Extension 2
NOT COMPLETED
|
174
|
76
|
|
Study Extension 3
STARTED
|
84
|
43
|
|
Study Extension 3
COMPLETED
|
69
|
39
|
|
Study Extension 3
NOT COMPLETED
|
15
|
4
|
Reasons for withdrawal
| Measure |
Immediate Switch Group (ISG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Day 1 to Week 24
Adverse Event
|
7
|
1
|
|
Day 1 to Week 24
Death
|
1
|
0
|
|
Day 1 to Week 24
Lack of Efficacy
|
0
|
1
|
|
Day 1 to Week 24
Lost to Follow-up
|
3
|
4
|
|
Day 1 to Week 24
Physician Decision
|
2
|
3
|
|
Day 1 to Week 24
Protocol Violation
|
1
|
4
|
|
Day 1 to Week 24
Withdrawal by Subject
|
6
|
1
|
|
Day 1 to Week 24
Randomized, not treated
|
3
|
0
|
|
Week 24 to Week 48
Adverse Event
|
6
|
2
|
|
Week 24 to Week 48
Lack of Efficacy
|
5
|
1
|
|
Week 24 to Week 48
Non-Compliance With Study Drug
|
0
|
1
|
|
Week 24 to Week 48
Physician Decision
|
2
|
1
|
|
Week 24 to Week 48
Withdrawal by Subject
|
5
|
2
|
|
Week 24 to Week 48
Lost to Follow-up
|
2
|
0
|
|
Study Extension 1
Adverse Event
|
7
|
5
|
|
Study Extension 1
Death
|
1
|
0
|
|
Study Extension 1
Lack of Efficacy
|
2
|
5
|
|
Study Extension 1
Lost to Follow-up
|
2
|
3
|
|
Study Extension 1
Non-compliance with study drug
|
3
|
0
|
|
Study Extension 1
Physician Decision
|
4
|
2
|
|
Study Extension 1
Pregnancy
|
1
|
0
|
|
Study Extension 1
Protocol Violation
|
0
|
1
|
|
Study Extension 1
Withdrawal by Subject
|
21
|
7
|
|
Study Extension 2
Adverse Event
|
3
|
3
|
|
Study Extension 2
Availability of study medication locally
|
152
|
64
|
|
Study Extension 2
Death
|
2
|
0
|
|
Study Extension 2
Lack of Efficacy
|
1
|
0
|
|
Study Extension 2
Lost to Follow-up
|
2
|
1
|
|
Study Extension 2
Non-compliance with study drug
|
1
|
0
|
|
Study Extension 2
Physician Decision
|
2
|
5
|
|
Study Extension 2
Pregnancy
|
1
|
0
|
|
Study Extension 2
Withdrawal by Subject
|
10
|
3
|
|
Study Extension 3
Adverse Event
|
1
|
0
|
|
Study Extension 3
Availability of study medication locally
|
11
|
3
|
|
Study Extension 3
Lost to Follow-up
|
1
|
0
|
|
Study Extension 3
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)
Baseline characteristics by cohort
| Measure |
Immediate Switch Group (ISG)
n=450 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=223 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Total
n=673 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
43.7 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
43.3 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
375 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
569 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
98 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
347 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
524 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
346 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
514 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
25 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24Population: All randomized participants who received at least 1 dose of study drug.
The percentage of participants in each arm achieving HIV-1 RNA levels \<50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=447 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=223 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
|
90.8 Percentage of Participants
|
94.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants in the ritonavir-boosted PI-based regimen who received at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.
To evaluate the effect on fasting LDL-C of an immediate switch to DOR/3TC/TDF on Study Day 1 compared with continuation of a ritonavir-boosted, PI-based regimen, as measured by mean change from baseline in each treatment group. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=256 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=125 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
Baseline
|
108.82 mg/dL
Standard Deviation 34.21
|
109.00 mg/dL
Standard Deviation 33.58
|
|
Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
Change from Baseline
|
-16.54 mg/dL
Standard Deviation 23.10
|
-1.94 mg/dL
Standard Deviation 25.74
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants who received the ritonavir-boosted PI-based regimen at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.
Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid lowering therapy.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=266 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=133 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Baseline
|
139.14 mg/dL
Standard Deviation 42.12
|
137.99 mg/dL
Standard Deviation 38.46
|
|
Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Change from Baseline
|
-24.74 mg/dL
Standard Deviation 29.26
|
-1.31 mg/dL
Standard Deviation 28.45
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants who received at least 1 dose of study drug.
The percentage of participants in each arm achieving HIV-1 RNA levels \<50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=447 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=223 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL
|
93.7 Percentage of Participants
|
94.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Immediate Switch to MK-1439A arm: Baseline and Week 48; Delayed Switch to MK-1439A arm: Baseline and Week 24Population: All randomized participants who received at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.
The mean change from baseline in CD4 cell counts was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm\^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=402 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=209 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
Baseline
|
660.5 cells/mm^3
Standard Deviation 293.4
|
655.6 cells/mm^3
Standard Deviation 279.3
|
|
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
Change from Baseline
|
13.9 cells/mm^3
Standard Deviation 168.1
|
18.0 cells/mm^3
Standard Deviation 157.7
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants who received at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.
The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm\^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=412 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=209 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
Baseline
|
664.5 cells/mm^3
Standard Deviation 300.7
|
655.6 cells/mm^3
Standard Deviation 279.3
|
|
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
Change from Baseline
|
5.1 cells/mm^3
Standard Deviation 174.9
|
18.0 cells/mm^3
Standard Deviation 157.7
|
SECONDARY outcome
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24Population: All randomized participants who received at least 1 dose of study drug.
The percentage of participants in each arm achieving HIV-1 RNA levels \<40 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=447 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=223 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
|
89.7 Percentage of Participants
|
93.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Immediate Switch to MK-1439A arm: Week 24; Delayed Switch to MK-1439A arm: Week 24Population: All randomized participants who received at least 1 dose of study drug.
To evaluate the immunological effect of an immediate switch to MK -1439A on Study Day 1 compared with continuation of a ritonavir boosted, PI-based regimen, as measured by the proportion of subjects maintaining HIV-1 RNA below the limit of quantification (BLoQ) by the Abbott RealTime HIV-1 Assay (\<40 copies/mL) in both treatment groups.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=447 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=223 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
|
92.8 Percentage of Participants
|
93.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24Population: All randomized participants who received at least 1 dose of study drug.
The percentage of participants in each arm achieving HIV-1 RNA levels \>=50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=447 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=223 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA >=50 Copies/mL
|
1.6 Percentage of Participants
|
1.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to week 24Population: All randomized participants who received at least 1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=447 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=223 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
|
68.9 Percentage of Participants
|
52.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: All randomized participants who received at least 1 dose of study drug.
A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=447 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=223 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)
|
2.9 Percentage of Participants
|
3.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: All randomized participants who received at least 1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Immediate Switch Group (ISG)
n=447 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
Delayed Switch Group (DSG)
n=223 Participants
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA continued on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|
|
Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
|
2.5 Percentage of Participants
|
0.4 Percentage of Participants
|
Adverse Events
ISG Base Study Weeks 0-24
Serious events: 13 serious events
Other events: 100 other events
Deaths: 1 deaths
DSG Base Study Weeks 0-24
Serious events: 8 serious events
Other events: 28 other events
Deaths: 0 deaths
ISG Base Study Weeks 24-48
Serious events: 11 serious events
Other events: 63 other events
Deaths: 0 deaths
DSG Base Study Weeks 24-48
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
ISG Study Extension 1
Serious events: 37 serious events
Other events: 107 other events
Deaths: 1 deaths
DSG Study Extension 1
Serious events: 13 serious events
Other events: 57 other events
Deaths: 0 deaths
ISG Study Extension 2
Serious events: 13 serious events
Other events: 24 other events
Deaths: 3 deaths
DSG Study Extension 2
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
ISG Study Extension 3
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
DSG Study Extension 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ISG Base Study Weeks 0-24
n=447 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Base Study Weeks 0-24
n=223 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
ISG Base Study Weeks 24-48
n=427 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Base Study Weeks 24-48
n=209 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
ISG Study Extension 1
n=398 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Study Extension 1
n=202 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
ISG Study Extension 2
n=303 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Study Extension 2
n=154 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
ISG Study Extension 3
n=84 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Study Extension 3
n=43 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
2/398 • Number of events 4 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Investigations
Lipase increased
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
2/398 • Number of events 2 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.75%
3/398 • Number of events 3 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.2%
1/84 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoma
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 2 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Lacunar infarction
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Behaviour disorder
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.2%
1/84 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.48%
1/209 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
2/398 • Number of events 2 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
2/398 • Number of events 3 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.48%
1/209 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.48%
1/209 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.99%
2/202 • Number of events 2 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.2%
1/84 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.48%
1/209 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.3%
3/223 • Number of events 3 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.99%
2/202 • Number of events 2 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 2 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Shigella infection
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.23%
1/427 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Syphilis
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.25%
1/398 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.22%
1/447 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.33%
1/303 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.50%
1/202 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/303 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
2.3%
1/43 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
Other adverse events
| Measure |
ISG Base Study Weeks 0-24
n=447 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Base Study Weeks 0-24
n=223 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
ISG Base Study Weeks 24-48
n=427 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Base Study Weeks 24-48
n=209 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
ISG Study Extension 1
n=398 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Study Extension 1
n=202 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
ISG Study Extension 2
n=303 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Study Extension 2
n=154 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
ISG Study Extension 3
n=84 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 (nuceloside/nucleotide reverse transcriptase inhibitors) NRTIs for \>=6 months with undetectable HIV-1 RNA switched on Day 1 to MK-1439A single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
DSG Study Extension 3
n=43 participants at risk
Participants received continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for \>=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they switched to MK-1439A single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
20/447 • Number of events 21 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
2.2%
5/223 • Number of events 5 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
3.0%
13/427 • Number of events 13 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
4.3%
9/209 • Number of events 10 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
4.5%
18/398 • Number of events 20 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
5.4%
11/202 • Number of events 14 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.99%
3/303 • Number of events 3 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/154 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.2%
1/84 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/447 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/223 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/427 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/209 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/398 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/202 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.3%
4/303 • Number of events 4 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
3.9%
6/154 • Number of events 6 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
8.3%
7/84 • Number of events 7 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
7.0%
3/43 • Number of events 3 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
33/447 • Number of events 34 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
5.4%
12/223 • Number of events 14 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
4.4%
19/427 • Number of events 21 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
4.3%
9/209 • Number of events 10 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
12.8%
51/398 • Number of events 68 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
14.4%
29/202 • Number of events 54 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.7%
5/303 • Number of events 5 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.3%
2/154 • Number of events 3 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
14/447 • Number of events 14 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
2.2%
5/223 • Number of events 5 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.9%
8/427 • Number of events 9 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.4%
3/209 • Number of events 5 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
5.3%
21/398 • Number of events 23 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
2.0%
4/202 • Number of events 4 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.7%
5/303 • Number of events 5 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.2%
1/84 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
9/447 • Number of events 9 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.8%
4/223 • Number of events 4 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
3.7%
16/427 • Number of events 16 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.48%
1/209 • Number of events 1 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
5.3%
21/398 • Number of events 22 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
4.5%
9/202 • Number of events 11 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
2.3%
7/303 • Number of events 7 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.3%
2/154 • Number of events 2 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
6.5%
29/447 • Number of events 32 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
2.2%
5/223 • Number of events 5 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
2.6%
11/427 • Number of events 11 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
6.7%
14/209 • Number of events 14 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
5.5%
22/398 • Number of events 24 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
6.4%
13/202 • Number of events 16 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.66%
2/303 • Number of events 3 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
1.9%
3/154 • Number of events 5 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/84 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
0.00%
0/43 • Up to ~338 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER