Trial Outcomes & Findings for Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021) (NCT NCT02403674)
NCT ID: NCT02403674
Last Updated: 2024-11-20
Results Overview
The percentage of participants in each arm with HIV-1 RNA levels \<50 copies/mL at Week 48 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 in which all missing data are considered treatment failures, regardless of the reason.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
734 participants
Primary outcome timeframe
Week 48
Results posted on
2024-11-20
Participant Flow
Treatment-naïve participants with HIV-1 infection have been recruited at 141 study sites worldwide. The present results include results from the base study (first 96-weeks of the study) along with study extension 1 (week 96-192), study extension 2 (week 192-288), and study extension 3 (week 288-384).
Participant milestones
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Base Study
STARTED
|
368
|
366
|
|
Base Study
Treated
|
364
|
364
|
|
Base Study
COMPLETED
|
296
|
276
|
|
Base Study
NOT COMPLETED
|
72
|
90
|
|
Study Extension 1 (Open-Label)
STARTED
|
291
|
269
|
|
Study Extension 1 (Open-Label)
COMPLETED
|
230
|
205
|
|
Study Extension 1 (Open-Label)
NOT COMPLETED
|
61
|
64
|
|
Study Extension 2 (Open-Label)
STARTED
|
192
|
173
|
|
Study Extension 2 (Open-Label)
COMPLETED
|
150
|
132
|
|
Study Extension 2 (Open-Label)
NOT COMPLETED
|
42
|
41
|
|
Study Extension 3 (Open-Label)
STARTED
|
121
|
111
|
|
Study Extension 3 (Open-Label)
COMPLETED
|
100
|
85
|
|
Study Extension 3 (Open-Label)
NOT COMPLETED
|
21
|
26
|
Reasons for withdrawal
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Base Study
Death
|
1
|
4
|
|
Base Study
Adverse Event
|
11
|
26
|
|
Base Study
Lack of Efficacy
|
31
|
23
|
|
Base Study
Lost to Follow-up
|
6
|
8
|
|
Base Study
Withdrawal by Subject
|
10
|
17
|
|
Base Study
Physician Decision
|
2
|
2
|
|
Base Study
Pregnancy
|
2
|
2
|
|
Base Study
Protocol Violation
|
8
|
4
|
|
Base Study
Non-Compliance with study drug
|
1
|
4
|
|
Study Extension 1 (Open-Label)
Adverse Event
|
1
|
4
|
|
Study Extension 1 (Open-Label)
Lack of Efficacy
|
10
|
13
|
|
Study Extension 1 (Open-Label)
Lost to Follow-up
|
8
|
5
|
|
Study Extension 1 (Open-Label)
Withdrawal by Subject
|
11
|
13
|
|
Study Extension 1 (Open-Label)
Physician Decision
|
2
|
5
|
|
Study Extension 1 (Open-Label)
Pregnancy
|
4
|
2
|
|
Study Extension 1 (Open-Label)
Death
|
1
|
0
|
|
Study Extension 1 (Open-Label)
Availability of study drug locally
|
22
|
19
|
|
Study Extension 1 (Open-Label)
Non-Compliance
|
2
|
3
|
|
Study Extension 2 (Open-Label)
Lack of Efficacy
|
1
|
1
|
|
Study Extension 2 (Open-Label)
Lost to Follow-up
|
1
|
7
|
|
Study Extension 2 (Open-Label)
Withdrawal by Subject
|
8
|
6
|
|
Study Extension 2 (Open-Label)
Physician Decision
|
1
|
1
|
|
Study Extension 2 (Open-Label)
Pregnancy
|
0
|
1
|
|
Study Extension 2 (Open-Label)
Death
|
2
|
2
|
|
Study Extension 2 (Open-Label)
Availability of study drug locally
|
27
|
23
|
|
Study Extension 2 (Open-Label)
Non-Compliance with study drug
|
2
|
0
|
|
Study Extension 3 (Open-Label)
Lost to Follow-up
|
5
|
4
|
|
Study Extension 3 (Open-Label)
Withdrawal by Subject
|
1
|
3
|
|
Study Extension 3 (Open-Label)
Physician Decision
|
1
|
5
|
|
Study Extension 3 (Open-Label)
Pregnancy
|
0
|
1
|
|
Study Extension 3 (Open-Label)
Availability of study drug locally
|
14
|
13
|
Baseline Characteristics
All randomized participants with baseline data available.
Baseline characteristics by cohort
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
Total
n=728 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.6 Years
STANDARD_DEVIATION 10.5 • n=364 Participants
|
32.7 Years
STANDARD_DEVIATION 9.9 • n=364 Participants
|
33.1 Years
STANDARD_DEVIATION 10.2 • n=728 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=364 Participants
|
53 Participants
n=364 Participants
|
112 Participants
n=728 Participants
|
|
Sex: Female, Male
Male
|
305 Participants
n=364 Participants
|
311 Participants
n=364 Participants
|
616 Participants
n=728 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=364 Participants
|
6 Participants
n=364 Participants
|
16 Participants
n=728 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=364 Participants
|
65 Participants
n=364 Participants
|
124 Participants
n=728 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=364 Participants
|
0 Participants
n=364 Participants
|
0 Participants
n=728 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=364 Participants
|
68 Participants
n=364 Participants
|
135 Participants
n=728 Participants
|
|
Race (NIH/OMB)
White
|
177 Participants
n=364 Participants
|
170 Participants
n=364 Participants
|
347 Participants
n=728 Participants
|
|
Race (NIH/OMB)
More than one race
|
51 Participants
n=364 Participants
|
55 Participants
n=364 Participants
|
106 Participants
n=728 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=364 Participants
|
0 Participants
n=364 Participants
|
0 Participants
n=728 Participants
|
|
Baseline cluster of differentiation 4 (CD4) cell counts
|
434.9 cells/mm^3
STANDARD_DEVIATION 217.9 • n=364 Participants
|
415.5 cells/mm^3
STANDARD_DEVIATION 210.6 • n=364 Participants
|
425.2 cells/mm^3
STANDARD_DEVIATION 214.3 • n=728 Participants
|
|
Baseline fasting low-density lipoprotein cholesterol (LDL-C)
|
92.08 mg/dL
STANDARD_DEVIATION 32.32 • n=353 Participants • All randomized participants with baseline data available.
|
90.47 mg/dL
STANDARD_DEVIATION 30.64 • n=352 Participants • All randomized participants with baseline data available.
|
91.27 mg/dL
STANDARD_DEVIATION 31.48 • n=705 Participants • All randomized participants with baseline data available.
|
|
Baseline fasting non-high-density lipoprotein cholesterol (non-HDL-C)
|
115.39 mg/dL
STANDARD_DEVIATION 34.67 • n=357 Participants • All randomized participants with baseline data available.
|
114.63 mg/dL
STANDARD_DEVIATION 33.55 • n=357 Participants • All randomized participants with baseline data available.
|
115.01 mg/dL
STANDARD_DEVIATION 34.09 • n=714 Participants • All randomized participants with baseline data available.
|
|
Baseline fasting cholesterol
|
157.29 mg/dL
STANDARD_DEVIATION 36.43 • n=357 Participants • All randomized participants with baseline data available.
|
156.07 mg/dL
STANDARD_DEVIATION 36.51 • n=357 Participants • All randomized participants with baseline data available.
|
156.68 mg/dL
STANDARD_DEVIATION 36.45 • n=714 Participants • All randomized participants with baseline data available.
|
|
Baseline fasting triglycerides
|
120.85 mg/dL
STANDARD_DEVIATION 83.06 • n=357 Participants • All randomized participants with baseline data available.
|
123.23 mg/dL
STANDARD_DEVIATION 82.73 • n=357 Participants • All randomized participants with baseline data available.
|
122.04 mg/dL
STANDARD_DEVIATION 82.84 • n=714 Participants • All randomized participants with baseline data available.
|
|
Baseline fasting high-density lipoprotein cholesterol (HDL-C)
|
41.90 mg/dL
STANDARD_DEVIATION 11.67 • n=357 Participants • All randomized participants with baseline data available.
|
41.44 mg/dL
STANDARD_DEVIATION 13.08 • n=357 Participants • All randomized participants with baseline data available.
|
41.67 mg/dL
STANDARD_DEVIATION 12.38 • n=714 Participants • All randomized participants with baseline data available.
|
PRIMARY outcome
Timeframe: Week 48Population: The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
The percentage of participants in each arm with HIV-1 RNA levels \<50 copies/mL at Week 48 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 in which all missing data are considered treatment failures, regardless of the reason.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
|
84.3 Percentage of Participants
|
80.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: The analysis population consists of all randomized participants who received ≥1 dose of study medication.
The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included "dizziness", "sleep disorders and disturbances", and "altered sensorium" (including disturbance in attention).
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
Dizziness
|
8.8 Percentage of Participants
|
37.1 Percentage of Participants
|
|
Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
Sleep disorders and disturbances
|
12.1 Percentage of Participants
|
25.5 Percentage of Participants
|
|
Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
Altered sensorium
|
4.4 Percentage of Participants
|
8.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 96Population: The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
The percentage of participants in each arm with HIV-1 RNA levels \<50 copies/mL at Week 96 were determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) were used for efficacy analyses.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
|
77.5 Percentage of participants
Interval 72.8 to 81.7
|
73.6 Percentage of participants
Interval 68.8 to 78.1
|
SECONDARY outcome
Timeframe: Week 48Population: The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
The percentage of participants in each arm with HIV-1 RNA levels \<40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV 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 in which all missing data are considered treatment failures, regardless of the reason.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
|
83.8 Percentage of Participants
Interval 79.6 to 87.4
|
79.7 Percentage of Participants
Interval 75.2 to 83.7
|
SECONDARY outcome
Timeframe: Week 96Population: The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
The percentage of participants in each arm with HIV-1 RNA levels \<40 copies/mL (including target detected and target not detected) at Week 96 were determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) were used for efficacy analyses.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96
|
76.1 Percentage of participants
Interval 71.4 to 80.4
|
72.8 Percentage of participants
Interval 67.9 to 77.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline and Week 48 CD4 data available.
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 prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm\^3, and percent change was then calculated as \[(Baseline counts - Week 48 counts)\*100\]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=344 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=329 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Change From Baseline in CD4 Cell Counts at Week 48
|
198.4 Percent Change from Baseline
Interval 180.2 to 216.7
|
188.4 Percent Change from Baseline
Interval 169.5 to 207.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 96Population: The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline and week 96 CD4 data available.
The mean change from baseline in CD4 cell counts at Week 96 were assessed using the OF approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 96 due to lack of efficacy. Cell counts at Baseline and Week 96 were measured and expressed as cells/mm\^3, and percent change was calculated as \[(Baseline counts - Week 96 counts)\*100\]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=337 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=311 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Change From Baseline in CD4 Cell Counts at Week 96
|
237.7 Percentage Change from Baseline
Interval 214.9 to 260.6
|
223.0 Percentage Change from Baseline
Interval 198.4 to 247.6
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The analysis population consisted of all randomized participants who received ≥1 dose of study medication.
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 |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants Experiencing ≥1 AE
|
82.7 Percentage of participants
|
90.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The analysis population consisted of all randomized participants who received ≥1 dose of study medication.
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 |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
|
3.0 Percentage of participants
|
6.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: The analysis population consists of all randomized participants who received ≥1 dose of study medication.
The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included "depression and suicide/self-injury" and "psychosis and psychotic disorders".
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants With Tier-2 Neuropsychiatric AEs
Depression and suicide/self-injury
|
4.1 Percentage of Participants
|
6.6 Percentage of Participants
|
|
Percentage of Participants With Tier-2 Neuropsychiatric AEs
Psychosis and psychotic disorders
|
0.3 Percentage of Participants
|
1.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The analysis population consists of all randomized participants who had baseline LDL-C data available as well as ≥1 LDL-C measurement after initiating study treatment.
The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. 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 |
MK-1439A (DOR/3TC/TDF From Day 1)
n=330 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=305 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Change From Baseline in Fasting LDL-C at Week 48
|
-1.58 Percent Change from Baseline
Interval -3.98 to 0.81
|
8.74 Percent Change from Baseline
Interval 5.86 to 11.62
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The analysis population consists of all randomized participants who had baseline non-HDL-C data available as well as ≥1 non-HDL-C measurement after initiating study treatment.
The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=333 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=314 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Change From Baseline in Fasting Non-HDL-C at Week 48
|
-3.83 Percent Change from Baseline
Interval -6.27 to -1.4
|
13.26 Percent Change from Baseline
Interval 10.07 to 16.45
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The analysis population consists of all randomized participants who had baseline cholesterol data available as well as ≥1 cholesterol measurement after initiating study treatment.
The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=333 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=314 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Change From Baseline in Fasting Cholesterol at Week 48
|
-1.97 Percent Change from Baseline
Interval -4.74 to 0.79
|
21.77 Percent Change from Baseline
Interval 18.35 to 25.18
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The analysis population consists of all randomized participants who had baseline triglyceride data available as well as ≥1 triglyceride measurement after initiating study treatment.
The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=333 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=314 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Change From Baseline in Fasting Triglycerides at Week 48
|
-12.40 Percent Change from Baseline
Interval -19.66 to -5.15
|
22.01 Percent Change from Baseline
Interval 11.68 to 32.34
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The analysis population consists of all randomized participants who had baseline HDL-C data available as well as ≥1 HDL-C measurement after initiating study treatment.
The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=333 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=314 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Change From Baseline in Fasting HDL-C at Week 48
|
1.86 Percent Change from Baseline
Interval 0.83 to 2.89
|
8.51 Percent Change from Baseline
Interval 7.32 to 9.69
|
SECONDARY outcome
Timeframe: Week 48Population: The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48
|
59.6 Percentage of Participants
|
55.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 96Population: The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 96 was determined. Plasma HIV RNA levels was quantified with the Abbott RealTime HIV-1 Assay. Data was handled as observed.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=364 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
n=364 Participants
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA BLoQ at Week 96
|
59.3 Percentage of Participants
|
59.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: 0 hours post-dose and 2 hours post-dose on Week 48Population: The analysis population consists of all randomized participants in the MK-1439A arm who received ≥1 dose of study drug and had doravirine concentration data available.
Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose.
Outcome measures
| Measure |
MK-1439A (DOR/3TC/TDF From Day 1)
n=312 Participants
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine (DOR) 100 mg + lamivudine (3TC) 300 mg + tenofovir disoproxil fumarate (TDF) 300 mg, once daily (q.d.) by mouth for 96 weeks. Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
ATRIPLA™ (Switch From EFV/FTC/TDF at Week 96)
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding. Eligible participants from the Base Study (Day 1 to Week 96) may have entered open-label optional study extensions to receive MK-1439A (FDC containing DOR 100 mg + 3TC 300 mg + TDF 300 mg), taken q.d. during Study Extension 1 (Weeks 96 to 192), Extension 2 (Weeks 192 to 288), and Extension 3 (Weeks 288 to 384).
|
|---|---|---|
|
Plasma Concentration of Doravirine at Week 48
Pre-dose
|
1290 nM
Standard Deviation 799
|
—
|
|
Plasma Concentration of Doravirine at Week 48
0.5 to 2 hours post-dose
|
2330 nM
Standard Deviation 1230
|
—
|
Adverse Events
DOR/3TC/TDF Only (From Day 1) at Base Study
Serious events: 22 serious events
Other events: 231 other events
Deaths: 1 deaths
DOR/3TC/TDF Switch at Week 96 Base Study
Serious events: 30 serious events
Other events: 281 other events
Deaths: 4 deaths
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 1
Serious events: 19 serious events
Other events: 111 other events
Deaths: 2 deaths
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 1
Serious events: 12 serious events
Other events: 110 other events
Deaths: 0 deaths
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 2
Serious events: 8 serious events
Other events: 0 other events
Deaths: 2 deaths
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 2
Serious events: 9 serious events
Other events: 0 other events
Deaths: 2 deaths
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 3
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 3
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DOR/3TC/TDF Only (From Day 1) at Base Study
n=364 participants at risk
Treatment-naive participants took a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for a total of 96 weeks.
|
DOR/3TC/TDF Switch at Week 96 Base Study
n=364 participants at risk
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for a total of 96 weeks.
|
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 1
n=291 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 96 - Week 192)
|
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 1
n=269 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 96 - Week 192)
|
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 2
n=192 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 192 - Week 288)
|
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 2
n=173 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 192 - Week 288)
|
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 3
n=121 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 388 - Week 384)
|
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 3
n=111 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 388 - Week 384)
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Cardiac disorders
Tachycardia
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
General disorders
Asthenia
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
General disorders
Death
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Hepatobiliary disorders
Cholangitis
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Abscess limb
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.52%
1/192 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Anal infection
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Appendicitis
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.90%
1/111 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Cellulitis
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Endometritis
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Hepatitis A
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.58%
1/173 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Oophoritis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Oral bacterial infection
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Pneumonia
|
0.55%
2/364 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Sepsis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.90%
1/111 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Viral infection
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.27%
1/364 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.52%
1/192 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.55%
2/364 • Number of events 4 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.55%
2/364 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Nervous system disorders
Seizure
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Nervous system disorders
Syncope
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.58%
1/173 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Psychiatric disorders
Nightmare
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 3 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 3 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.27%
1/364 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.58%
1/173 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Orchitis mumps
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.58%
1/173 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.69%
2/291 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.58%
1/173 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.52%
1/192 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.52%
1/192 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.52%
1/192 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Acute hepatitis C
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.52%
1/192 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.58%
1/173 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.52%
1/192 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.58%
1/173 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.58%
1/173 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.52%
1/192 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.90%
1/111 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
General disorders
Inflammation
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.90%
1/111 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.83%
1/121 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
1.8%
2/111 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.90%
1/111 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.90%
1/111 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.90%
1/111 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.90%
1/111 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.83%
1/121 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.83%
1/121 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.37%
1/269 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.74%
2/269 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic large-cell lymphoma
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/173 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.90%
1/111 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Renal and urinary disorders
Mania
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/364 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/269 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/192 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.58%
1/173 • Number of events 1 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/121 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/111 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
Other adverse events
| Measure |
DOR/3TC/TDF Only (From Day 1) at Base Study
n=364 participants at risk
Treatment-naive participants took a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for a total of 96 weeks.
|
DOR/3TC/TDF Switch at Week 96 Base Study
n=364 participants at risk
Treatment-naive participants with HIV-1 infection took ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for a total of 96 weeks.
|
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 1
n=291 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 96 - Week 192)
|
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 1
n=269 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 96 - Week 192)
|
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 2
n=192 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 192 - Week 288)
|
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 2
n=173 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 192 - Week 288)
|
DOR/3TC/TDF Only (DOR/3TC/TDF From Day 1) Ext 3
n=121 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 388 - Week 384)
|
DOR/3TC/TDF Switch (Switch From EFV/FTC/TDF at Week 96) Ext 3
n=111 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 388 - Week 384)
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
50/364 • Number of events 73 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
15.9%
58/364 • Number of events 68 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
5.5%
16/291 • Number of events 21 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
6.3%
17/269 • Number of events 18 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Gastrointestinal disorders
Nausea
|
8.5%
31/364 • Number of events 35 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
11.5%
42/364 • Number of events 55 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
1.7%
5/291 • Number of events 5 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
2.6%
7/269 • Number of events 8 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
19/364 • Number of events 23 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
8.0%
29/364 • Number of events 42 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.34%
1/291 • Number of events 3 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
1.5%
4/269 • Number of events 4 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
General disorders
Fatigue
|
6.0%
22/364 • Number of events 25 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
6.6%
24/364 • Number of events 26 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
1.4%
4/291 • Number of events 4 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
1.9%
5/269 • Number of events 5 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
13.7%
50/364 • Number of events 89 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
11.8%
43/364 • Number of events 61 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
13.7%
40/291 • Number of events 58 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
9.7%
26/269 • Number of events 36 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Pharyngitis
|
8.2%
30/364 • Number of events 39 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
5.5%
20/364 • Number of events 27 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
4.5%
13/291 • Number of events 16 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
4.1%
11/269 • Number of events 18 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.3%
41/364 • Number of events 55 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
8.2%
30/364 • Number of events 40 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
7.2%
21/291 • Number of events 33 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
7.1%
19/269 • Number of events 22 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
18/364 • Number of events 23 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
5.2%
19/364 • Number of events 21 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
2.4%
7/291 • Number of events 7 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
5.2%
14/269 • Number of events 15 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Nervous system disorders
Dizziness
|
10.2%
37/364 • Number of events 47 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
38.2%
139/364 • Number of events 155 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.69%
2/291 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
1.5%
4/269 • Number of events 4 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Nervous system disorders
Headache
|
15.9%
58/364 • Number of events 96 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
15.4%
56/364 • Number of events 77 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
6.2%
18/291 • Number of events 19 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
5.9%
16/269 • Number of events 21 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Nervous system disorders
Somnolence
|
3.6%
13/364 • Number of events 13 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
7.7%
28/364 • Number of events 28 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.69%
2/291 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.74%
2/269 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Psychiatric disorders
Abnormal dreams
|
4.9%
18/364 • Number of events 20 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
12.1%
44/364 • Number of events 49 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.00%
0/291 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
0.74%
2/269 • Number of events 2 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Psychiatric disorders
Insomnia
|
6.6%
24/364 • Number of events 35 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
10.4%
38/364 • Number of events 42 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
2.1%
6/291 • Number of events 7 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
3.7%
10/269 • Number of events 10 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
22/364 • Number of events 25 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
5.5%
20/364 • Number of events 24 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
2.7%
8/291 • Number of events 8 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
4.1%
11/269 • Number of events 12 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
20/364 • Number of events 22 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
13.7%
50/364 • Number of events 54 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
2.7%
8/291 • Number of events 9 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
1.9%
5/269 • Number of events 5 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
|
Infections and infestations
Syphilis
|
4.9%
18/364 • Number of events 21 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
3.8%
14/364 • Number of events 15 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
5.5%
16/291 • Number of events 18 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
5.6%
15/269 • Number of events 17 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
—
0/0 • Up to 430 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 430 weeks, and non-serious adverse event data were collected up to 192 weeks.
|
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 trial 45 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER