Trial Outcomes & Findings for Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028) (NCT NCT02652260)
NCT ID: NCT02652260
Last Updated: 2025-02-07
Results Overview
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
Week 12
Results posted on
2025-02-07
Participant Flow
Out of 112 participants screened, 86 were randomized and received study treatment.
Participant milestones
| Measure |
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening were switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks. Eligible participants from Base Study (Day 1 to Week 24) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 24 to 120), Extension 2 (Weeks 120 to 216), and Extension 3 (Weeks 216 to 312).
|
Deferred Switch to MK-1439A
Participants continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks (Day 1 to Week 12), followed by open-label MK-1439A orally, once daily for 24 weeks (Weeks 12 to 36). Eligible participants from Base Study (Day 1 to Week 36) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 36 to 132), Extension 2 (Weeks 132 to 228), and Extension 3 (Weeks 228 to 324).
|
|---|---|---|
|
Base Study
STARTED
|
43
|
43
|
|
Base Study
Switched Over to MK-1439A
|
0
|
42
|
|
Base Study
COMPLETED
|
43
|
41
|
|
Base Study
NOT COMPLETED
|
0
|
2
|
|
Study Extension 1 (Open-Label)
STARTED
|
43
|
41
|
|
Study Extension 1 (Open-Label)
COMPLETED
|
39
|
34
|
|
Study Extension 1 (Open-Label)
NOT COMPLETED
|
4
|
7
|
|
Study Extension 2 (Open-Label)
STARTED
|
39
|
33
|
|
Study Extension 2 (Open-Label)
COMPLETED
|
17
|
19
|
|
Study Extension 2 (Open-Label)
NOT COMPLETED
|
22
|
14
|
|
Study Extension 3 (Open-Label)
STARTED
|
17
|
19
|
|
Study Extension 3 (Open-Label)
COMPLETED
|
10
|
8
|
|
Study Extension 3 (Open-Label)
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
| Measure |
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening were switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks. Eligible participants from Base Study (Day 1 to Week 24) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 24 to 120), Extension 2 (Weeks 120 to 216), and Extension 3 (Weeks 216 to 312).
|
Deferred Switch to MK-1439A
Participants continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks (Day 1 to Week 12), followed by open-label MK-1439A orally, once daily for 24 weeks (Weeks 12 to 36). Eligible participants from Base Study (Day 1 to Week 36) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 36 to 132), Extension 2 (Weeks 132 to 228), and Extension 3 (Weeks 228 to 324).
|
|---|---|---|
|
Base Study
Pregnancy
|
0
|
1
|
|
Base Study
Withdrawal by Subject
|
0
|
1
|
|
Study Extension 1 (Open-Label)
Withdrawal by Subject
|
1
|
2
|
|
Study Extension 1 (Open-Label)
Pregnancy
|
1
|
1
|
|
Study Extension 1 (Open-Label)
Lack of Efficacy
|
1
|
1
|
|
Study Extension 1 (Open-Label)
Availability of study drug locally
|
1
|
1
|
|
Study Extension 1 (Open-Label)
Adverse Event
|
0
|
2
|
|
Study Extension 2 (Open-Label)
Adverse Event
|
1
|
0
|
|
Study Extension 2 (Open-Label)
Availability of study drug locally
|
18
|
13
|
|
Study Extension 2 (Open-Label)
Lost to Follow-up
|
1
|
0
|
|
Study Extension 2 (Open-Label)
Non-Compliance with study drug
|
1
|
0
|
|
Study Extension 2 (Open-Label)
Pregnancy
|
1
|
1
|
|
Study Extension 3 (Open-Label)
Physician Decision
|
7
|
10
|
|
Study Extension 3 (Open-Label)
Pregnancy
|
0
|
1
|
Baseline Characteristics
All randomized participants who received at least one dose of study treatment.
Baseline characteristics by cohort
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks. Eligible participants from Base Study (Day 1 to Week 24) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 24 to 120), Extension 2 (Weeks 120 to 216), and Extension 3 (Weeks 216 to 312).
|
Deferred Switch to MK-1439A
n=43 Participants
Participants continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks (Day 1 to Week 12), followed by open-label MK-1439A orally, once daily for 24 weeks (Weeks 12 to 36). Eligible participants from Base Study (Day 1 to Week 36) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 36 to 132), Extension 2 (Weeks 132 to 228), and Extension 3 (Weeks 228 to 324).
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 Years
STANDARD_DEVIATION 11.9 • n=43 Participants
|
41.6 Years
STANDARD_DEVIATION 11.2 • n=43 Participants
|
41.7 Years
STANDARD_DEVIATION 11.5 • n=86 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=43 Participants
|
17 Participants
n=43 Participants
|
36 Participants
n=86 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=43 Participants
|
26 Participants
n=43 Participants
|
50 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=43 Participants
|
1 Participants
n=43 Participants
|
5 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=43 Participants
|
42 Participants
n=43 Participants
|
81 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=43 Participants
|
1 Participants
n=43 Participants
|
4 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=43 Participants
|
23 Participants
n=43 Participants
|
48 Participants
n=86 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=43 Participants
|
19 Participants
n=43 Participants
|
31 Participants
n=86 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
3 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=86 Participants
|
|
CNS Toxicity Percentage Of Maximum Score
|
32.9 Percentage of maximum score
STANDARD_DEVIATION 16.5 • n=43 Participants
|
37.1 Percentage of maximum score
STANDARD_DEVIATION 19.0 • n=43 Participants
|
35.0 Percentage of maximum score
STANDARD_DEVIATION 17.8 • n=86 Participants
|
|
Fasting Lipids
LDL Cholesterol
|
98.67 mg/dL
STANDARD_DEVIATION 35.28 • n=36 Participants • All randomized participants who received at least one dose of study treatment.
|
99.54 mg/dL
STANDARD_DEVIATION 33.57 • n=41 Participants • All randomized participants who received at least one dose of study treatment.
|
99.13 mg/dL
STANDARD_DEVIATION 34.15 • n=77 Participants • All randomized participants who received at least one dose of study treatment.
|
|
Fasting Lipids
Non-HDL Cholesterol
|
118.73 mg/dL
STANDARD_DEVIATION 36.93 • n=37 Participants • All randomized participants who received at least one dose of study treatment.
|
117.76 mg/dL
STANDARD_DEVIATION 37.83 • n=41 Participants • All randomized participants who received at least one dose of study treatment.
|
118.22 mg/dL
STANDARD_DEVIATION 37.16 • n=78 Participants • All randomized participants who received at least one dose of study treatment.
|
|
Fasting Lipids
Cholesterol
|
178.11 mg/dL
STANDARD_DEVIATION 36.39 • n=37 Participants • All randomized participants who received at least one dose of study treatment.
|
173.02 mg/dL
STANDARD_DEVIATION 36.62 • n=41 Participants • All randomized participants who received at least one dose of study treatment.
|
175.44 mg/dL
STANDARD_DEVIATION 36.37 • n=78 Participants • All randomized participants who received at least one dose of study treatment.
|
|
Fasting Lipids
HDL Cholesterol
|
59.38 mg/dL
STANDARD_DEVIATION 14.58 • n=37 Participants • All randomized participants who received at least one dose of study treatment.
|
55.27 mg/dL
STANDARD_DEVIATION 14.00 • n=41 Participants • All randomized participants who received at least one dose of study treatment.
|
57.22 mg/dL
STANDARD_DEVIATION 14.34 • n=78 Participants • All randomized participants who received at least one dose of study treatment.
|
|
Fasting Lipids
Triglyceride
|
107.49 mg/dL
STANDARD_DEVIATION 65.64 • n=37 Participants • All randomized participants who received at least one dose of study treatment.
|
91.39 mg/dL
STANDARD_DEVIATION 39.43 • n=41 Participants • All randomized participants who received at least one dose of study treatment.
|
99.03 mg/dL
STANDARD_DEVIATION 53.73 • n=78 Participants • All randomized participants who received at least one dose of study treatment.
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=43 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12
|
41.9 Percentage of participants
|
37.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=43 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4
|
46.5 Percentage of participants
|
65.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=43 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in CNS Toxicity Score at Week 4
|
-17.6 Percentage of maximum score
Interval -23.4 to -11.8
|
-15.6 Percentage of maximum score
Interval -22.0 to -9.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=43 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in CNS Toxicity Score at Week 12
|
-18.1 Percentage of maximum score
Interval -22.9 to -13.3
|
-21.7 Percentage of maximum score
Interval -27.9 to -15.5
|
SECONDARY outcome
Timeframe: Baseline (time of switch) and 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. For the Immediate Switch Group (ISG) time of switch was study Day 1, and week 24 post-switch was week 24. For the Delayed Switch Group (DSG) time of switch was study week 12, and week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=86 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=86 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
|
68.6 Percentage of participants
|
30.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (time of switch) and 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A higher CNS score indicates worse symptoms. A positive change in CNS score indicates worsening symptoms. A negative change indicates improvement in symptoms. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=86 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=86 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
|
24.2 Percentage of maximum score
Interval 20.5 to 27.9
|
10.7 Percentage of maximum score
Interval 8.7 to 12.8
|
SECONDARY outcome
Timeframe: Baseline (study Day 1) and study week 12Population: All randomized participants who received at least one dose of study treatment, and have required lipid data.
Blood was collected under fasting conditions on Day 1 and on week 12 in order to determine the concentration of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=37 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=41 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Lipids at Week 12
LDL Cholesterol
|
-10.78 mg/dL
Standard Deviation 15.85
|
-1.88 mg/dL
Standard Deviation 14.88
|
|
Change From Baseline in Fasting Lipids at Week 12
Non-HDL Cholesterol
|
-14.08 mg/dL
Standard Deviation 17.17
|
-0.37 mg/dL
Standard Deviation 16.51
|
|
Change From Baseline in Fasting Lipids at Week 12
Cholesterol
|
-22.14 mg/dL
Standard Deviation 19.49
|
0.00 mg/dL
Standard Deviation 18.04
|
|
Change From Baseline in Fasting Lipids at Week 12
HDL Cholesterol
|
-8.05 mg/dL
Standard Deviation 7.74
|
0.37 mg/dL
Standard Deviation 7.91
|
|
Change From Baseline in Fasting Lipids at Week 12
Triglyceride
|
-21.19 mg/dL
Standard Deviation 43.37
|
7.10 mg/dL
Standard Deviation 38.55
|
SECONDARY outcome
Timeframe: Baseline (time of switch) and 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have required lipid data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
Blood was collected under fasting conditions at time of switch and 24 weeks post-switch in order to determine the change from baseline of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=76 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
LDL Cholesterol
|
-10.97 mg/dL
Standard Deviation 17.15
|
—
|
|
Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
Non-HDL Cholesterol
|
-13.18 mg/dL
Standard Deviation 19.82
|
—
|
|
Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
Cholesterol
|
-20.91 mg/dL
Standard Deviation 20.19
|
—
|
|
Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
HDL Cholesterol
|
-7.72 mg/dL
Standard Deviation 9.53
|
—
|
|
Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
Triglyceride
|
-12.99 mg/dL
Standard Deviation 46.61
|
—
|
SECONDARY outcome
Timeframe: 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have required HIV-1 RNA data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
Blood was collected under fasting conditions at 24 weeks post-switch in order to determine the HIV-1 RNA. For the ISG week 24 post-switch was week 24. For the DSG week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=85 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups
< 50 copies/mL
|
95.3 Percentage of participants
Interval 88.4 to 98.7
|
—
|
|
Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups
< 40 copies/mL
|
95.3 Percentage of participants
Interval 88.4 to 98.7
|
—
|
SECONDARY outcome
Timeframe: Baseline (time of switch) and 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have required CD4 T-cell data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
Blood was collected at time of switch and at 24 weeks post-switch in order to determine the CD4 T-cell count. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=85 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups
|
70.4 cells/mm^3
Interval 35.9 to 104.8
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12Population: All randomized participants who received at least one dose of study treatment.
An adverse event (AE) is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=43 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With One or More Adverse Events (AEs) Through Study Week 12
|
34 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: All randomized participants who received at least one dose of study treatment.
An adverse event (AE) is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=43 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With One or More Drug-related AEs Through Study Week 12
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: All randomized participants who received at least one dose of study treatment.
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=43 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: All randomized participants who received at least one dose of study treatment.
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=43 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With One or More Drug-related SAEs Through Study Week 12
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: All randomized participants who received at least one dose of study treatment.
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=43 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
n=43 Participants
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=85 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch
|
71 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=85 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With One or More Drug-related AEs for the Combined Treatment Groups 24 Weeks After the Switch
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=85 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=85 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With One or More Drug-related SAEs for the Combined Treatment Groups 24 Weeks After the Switch
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeks post-switchPopulation: All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
Outcome measures
| Measure |
Immediate Switch to MK-1439A
n=85 Participants
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
|
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch
|
0 Participants
|
—
|
Adverse Events
Immediate Switch to MK-1439A (Day 1 to Week 24)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Deferred Switch to MK-1439A (Day 1 to Week 12)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Deferred Switch to MK-1439A (Week 12-36)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Immediate Switch to MK-1439A EXT 1 (Week 24-120)
Serious events: 6 serious events
Other events: 31 other events
Deaths: 0 deaths
Deferred Switch to MK-1439A EXT 1 (Week 36-132)
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Immediate Switch to MK-1439A EXT 2 (Week 120-216)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Deferred Switch to MK-1439A EXT 2 (Week 132-228)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Immediate Switch to MK-1439A EXT 3 (Week 216-312)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Deferred Switch to MK-1439A EXT 3 (Week 228-324)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Switch to MK-1439A (Day 1 to Week 24)
n=43 participants at risk
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening switched to blinded doravirine, tenofovir, lamivudine orally, once daily for 12 weeks, followed by open-label doravirine, tenofovir, lamivudine orally, once daily for an additional 12 weeks
|
Deferred Switch to MK-1439A (Day 1 to Week 12)
n=43 participants at risk
Participants continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks.
|
Deferred Switch to MK-1439A (Week 12-36)
n=42 participants at risk
Participants who continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks switched to open-label doravirine, tenofovir, lamivudine orally, once daily for a total of 24 weeks (Week 12 - Week 36).
|
Immediate Switch to MK-1439A EXT 1 (Week 24-120)
n=43 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 24 - Week 120)
|
Deferred Switch to MK-1439A EXT 1 (Week 36-132)
n=41 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 36 - Week 132)
|
Immediate Switch to MK-1439A EXT 2 (Week 120-216)
n=39 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 120 - Week 216)
|
Deferred Switch to MK-1439A EXT 2 (Week 132-228)
n=33 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 132 - Week 228)
|
Immediate Switch to MK-1439A EXT 3 (Week 216-312)
n=17 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 216 - Week 312)
|
Deferred Switch to MK-1439A EXT 3 (Week 228-324)
n=19 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 228 - Week 324)
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
3.0%
1/33 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.4%
1/41 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Viral infection
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
3.0%
1/33 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
5.9%
1/17 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.4%
1/42 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.6%
1/39 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
5.9%
1/17 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.6%
1/39 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.4%
1/41 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/39 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/17 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.6%
1/39 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/33 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
5.9%
1/17 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/19 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
Other adverse events
| Measure |
Immediate Switch to MK-1439A (Day 1 to Week 24)
n=43 participants at risk
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening switched to blinded doravirine, tenofovir, lamivudine orally, once daily for 12 weeks, followed by open-label doravirine, tenofovir, lamivudine orally, once daily for an additional 12 weeks
|
Deferred Switch to MK-1439A (Day 1 to Week 12)
n=43 participants at risk
Participants continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks.
|
Deferred Switch to MK-1439A (Week 12-36)
n=42 participants at risk
Participants who continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks switched to open-label doravirine, tenofovir, lamivudine orally, once daily for a total of 24 weeks (Week 12 - Week 36).
|
Immediate Switch to MK-1439A EXT 1 (Week 24-120)
n=43 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 24 - Week 120)
|
Deferred Switch to MK-1439A EXT 1 (Week 36-132)
n=41 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 36 - Week 132)
|
Immediate Switch to MK-1439A EXT 2 (Week 120-216)
n=39 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 120 - Week 216)
|
Deferred Switch to MK-1439A EXT 2 (Week 132-228)
n=33 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 132 - Week 228)
|
Immediate Switch to MK-1439A EXT 3 (Week 216-312)
n=17 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 216 - Week 312)
|
Deferred Switch to MK-1439A EXT 3 (Week 228-324)
n=19 participants at risk
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 228 - Week 324)
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.6%
5/43 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.4%
1/42 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.9%
2/41 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.7%
2/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.8%
4/41 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
6/43 • Number of events 6 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.0%
3/43 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.5%
4/42 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.8%
4/41 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Gastroenteritis
|
7.0%
3/43 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.9%
2/41 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Influenza
|
4.7%
2/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.8%
2/42 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.3%
4/43 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/41 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.3%
4/43 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.8%
4/41 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
2/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.7%
2/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.8%
2/42 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.3%
4/43 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.9%
2/41 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.3%
4/43 • Number of events 6 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
14.0%
6/43 • Number of events 6 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.8%
2/42 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.3%
4/43 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
17.1%
7/41 • Number of events 8 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Viral infection
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.3%
3/41 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.4%
1/42 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.7%
2/43 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.3%
3/41 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.3%
7/43 • Number of events 8 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.8%
2/42 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.3%
4/43 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.3%
3/41 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
3/43 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.4%
1/42 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
11.6%
5/43 • Number of events 6 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.9%
2/41 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Nervous system disorders
Disturbance in attention
|
7.0%
3/43 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.3%
4/43 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.5%
4/42 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.3%
4/43 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
12.2%
5/41 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Nervous system disorders
Dizziness
|
16.3%
7/43 • Number of events 7 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
11.6%
5/43 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
11.9%
5/42 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
11.6%
5/43 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
12.2%
5/41 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Nervous system disorders
Headache
|
25.6%
11/43 • Number of events 13 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
16.3%
7/43 • Number of events 9 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.1%
3/42 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
18.6%
8/43 • Number of events 8 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
34.1%
14/41 • Number of events 15 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Nervous system disorders
Somnolence
|
14.0%
6/43 • Number of events 8 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.0%
3/43 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
11.9%
5/42 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
20.9%
9/43 • Number of events 9 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
17.1%
7/41 • Number of events 9 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Psychiatric disorders
Abnormal dreams
|
11.6%
5/43 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.0%
3/43 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.1%
3/42 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
11.6%
5/43 • Number of events 6 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
12.2%
5/41 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Psychiatric disorders
Aggression
|
7.0%
3/43 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.7%
2/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.8%
2/42 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.3%
4/43 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
17.1%
7/41 • Number of events 7 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Psychiatric disorders
Anxiety
|
4.7%
2/43 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.7%
2/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
16.7%
7/42 • Number of events 7 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
16.3%
7/43 • Number of events 7 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
26.8%
11/41 • Number of events 11 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Psychiatric disorders
Confusional state
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.1%
3/42 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
14.0%
6/43 • Number of events 6 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
14.6%
6/41 • Number of events 7 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Psychiatric disorders
Depressed mood
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.7%
2/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
11.6%
5/43 • Number of events 6 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.9%
2/41 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Psychiatric disorders
Depression
|
7.0%
3/43 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
9.5%
4/42 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
11.6%
5/43 • Number of events 7 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
19.5%
8/41 • Number of events 8 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Psychiatric disorders
Insomnia
|
18.6%
8/43 • Number of events 9 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
16.3%
7/43 • Number of events 10 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
14.3%
6/42 • Number of events 6 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
11.6%
5/43 • Number of events 5 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
24.4%
10/41 • Number of events 13 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
2/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.8%
2/42 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.0%
3/43 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.9%
2/41 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
4.7%
2/43 • Number of events 2 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/42 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
7.0%
3/43 • Number of events 3 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.4%
1/41 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.0%
3/43 • Number of events 4 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.3%
1/43 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.4%
1/42 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
0.00%
0/43 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
2.4%
1/41 • Number of events 1 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
|
—
0/0 • Up to approximately 326 weeks
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 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. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER