Trial Outcomes & Findings for A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects (NCT NCT00951015)
NCT ID: NCT00951015
Last Updated: 2018-01-16
Results Overview
Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (\<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).ITT-E Population included all randomized participants who received at least one dose of study medication
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
Week 16
Results posted on
2018-01-16
Participant Flow
Randomization Phase participants received Dolutegravir (DTG 10, 25 or 50 milligrams\[mg\]) with Placebo/Efavirenz (EFV) for 96 Weeks . DTG participants who completed 96 Weeks continued or were switched to receive DTG 50 mg in Open label phase until DTG was locally available.
A total of 278 par were screened of which 70 were screen failures and 208 were randomized; 205 received at least one dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population. 17 participants out of 155 from DTG arm withdrew during Randomization phase and total 138 participants were enrolled in an Open-label phase.
Participant milestones
| Measure |
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and Abacavir/lamivudine (ABC/3TC) 600 mg/300 mg or tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
Participants received DTG 50 mg matching placebo and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Open-label DTG 50 mg QD
All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
|
|---|---|---|---|---|---|
|
Randomization Phase 96 Week
STARTED
|
53
|
51
|
51
|
50
|
0
|
|
Randomization Phase 96 Week
COMPLETED
|
48
|
44
|
46
|
40
|
0
|
|
Randomization Phase 96 Week
NOT COMPLETED
|
5
|
7
|
5
|
10
|
0
|
|
Open-label Phase
STARTED
|
0
|
0
|
0
|
0
|
138
|
|
Open-label Phase
COMPLETED
|
0
|
0
|
0
|
0
|
88
|
|
Open-label Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
50
|
Reasons for withdrawal
| Measure |
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and Abacavir/lamivudine (ABC/3TC) 600 mg/300 mg or tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
Participants received DTG 50 mg matching placebo and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Open-label DTG 50 mg QD
All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
|
|---|---|---|---|---|---|
|
Randomization Phase 96 Week
Adverse Event
|
1
|
1
|
2
|
5
|
0
|
|
Randomization Phase 96 Week
Lack of Efficacy
|
1
|
1
|
0
|
0
|
0
|
|
Randomization Phase 96 Week
Protocol Violation
|
1
|
1
|
1
|
0
|
0
|
|
Randomization Phase 96 Week
Protocol-Defined Stopping Criteria
|
0
|
0
|
0
|
1
|
0
|
|
Randomization Phase 96 Week
Lost to Follow-up
|
0
|
3
|
1
|
2
|
0
|
|
Randomization Phase 96 Week
Withdrawal by Subject
|
2
|
1
|
1
|
2
|
0
|
|
Open-label Phase
Adverse Event
|
0
|
0
|
0
|
0
|
3
|
|
Open-label Phase
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Open-label Phase
Protocol Violation
|
0
|
0
|
0
|
0
|
12
|
|
Open-label Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
12
|
|
Open-label Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
14
|
|
Open-label Phase
Physician Decision
|
0
|
0
|
0
|
0
|
8
|
Baseline Characteristics
A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects
Baseline characteristics by cohort
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.2 Years
STANDARD_DEVIATION 9.25 • n=5 Participants
|
37.0 Years
STANDARD_DEVIATION 9.79 • n=7 Participants
|
37.0 Years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
40.7 Years
STANDARD_DEVIATION 11.19 • n=4 Participants
|
37.2 Years
STANDARD_DEVIATION 10.00 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
177 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage (HER)
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
4 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian HER/South East Asian HER
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
41 participants
n=5 Participants
|
42 participants
n=7 Participants
|
38 participants
n=5 Participants
|
43 participants
n=4 Participants
|
164 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African HER & White
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian & White
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: ITT-E Population
Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (\<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).ITT-E Population included all randomized participants who received at least one dose of study medication
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16
|
51 participants
|
47 participants
|
46 participants
|
29 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: ITT-E Population.
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline and Week 2. Viral change is defined as the change in plasma HIV-1 RNA over the initial 2 weeks of treatment, calculated as the value at Week 2 minus the value at Baseline. Only those participants available at the specified time point were analyzed.
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=50 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=50 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=48 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Viral Change Over the Initial 2 Weeks of Treatment
|
-2.387 Log10 c/mL
Standard Deviation 0.4595
|
-2.365 Log10 c/mL
Standard Deviation 0.5458
|
-2.392 Log10 c/mL
Standard Deviation 0.4241
|
-1.930 Log10 c/mL
Standard Deviation 0.4312
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 1, n=53, 50, 48, 50
|
-1.815 Log10 c/mL
Standard Deviation 0.3999
|
-1.773 Log10 c/mL
Standard Deviation 0.4650
|
-1.738 Log10 c/mL
Standard Deviation 0.3840
|
-1.562 Log10 c/mL
Standard Deviation 0.4158
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 2, n=53, 50, 50, 48
|
-2.387 Log10 c/mL
Standard Deviation 0.4595
|
-2.365 Log10 c/mL
Standard Deviation 0.5458
|
-2.392 Log10 c/mL
Standard Deviation 0.4241
|
-1.930 Log10 c/mL
Standard Deviation 0.4312
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 4, n=53, 50, 50, 45
|
-2.629 Log10 c/mL
Standard Deviation 0.5863
|
-2.583 Log10 c/mL
Standard Deviation 0.6337
|
-2.713 Log10 c/mL
Standard Deviation 0.5471
|
-2.162 Log10 c/mL
Standard Deviation 0.5400
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 8, n=52, 50, 49, 45
|
-2.657 Log10 c/mL
Standard Deviation 0.6980
|
-2.666 Log10 c/mL
Standard Deviation 0.6667
|
-2.848 Log10 c/mL
Standard Deviation 0.6556
|
-2.450 Log10 c/mL
Standard Deviation 0.5989
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 12, n=53, 49, 49, 45
|
-2.685 Log10 c/mL
Standard Deviation 0.6831
|
-2.671 Log10 c/mL
Standard Deviation 0.6850
|
-2.860 Log10 c/mL
Standard Deviation 0.6772
|
-2.603 Log10 c/mL
Standard Deviation 0.5869
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 32, n=52, 49, 47, 45
|
-2.717 Log10 c/mL
Standard Deviation 0.6588
|
-2.658 Log10 c/mL
Standard Deviation 0.6991
|
-2.855 Log10 c/mL
Standard Deviation 0.6963
|
-2.772 Log10 c/mL
Standard Deviation 0.7021
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 60, n=50, 48, 48, 44
|
-2.741 Log10 c/mL
Standard Deviation 0.6444
|
-2.675 Log10 c/mL
Standard Deviation 0.7012
|
-2.825 Log10 c/mL
Standard Deviation 0.7458
|
-2.765 Log10 c/mL
Standard Deviation 0.7035
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 72, n=51, 47, 48, 44
|
-2.742 Log10 c/mL
Standard Deviation 0.6453
|
-2.622 Log10 c/mL
Standard Deviation 0.8052
|
-2.860 Log10 c/mL
Standard Deviation 0.6930
|
-2.757 Log10 c/mL
Standard Deviation 0.7094
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 84, n=51, 47, 47, 43
|
-2.725 Log10 c/mL
Standard Deviation 0.6506
|
-2.670 Log10 c/mL
Standard Deviation 0.7064
|
-2.855 Log10 c/mL
Standard Deviation 0.6923
|
-2.743 Log10 c/mL
Standard Deviation 0.7321
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 16, n=52, 49, 49, 45
|
-2.718 Log10 c/mL
Standard Deviation 0.6593
|
-2.668 Log10 c/mL
Standard Deviation 0.6826
|
-2.859 Log10 c/mL
Standard Deviation 0.6876
|
-2.698 Log10 c/mL
Standard Deviation 0.6715
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 20, n=52, 48, 49, 44
|
-2.701 Log10 c/mL
Standard Deviation 0.6423
|
-2.662 Log10 c/mL
Standard Deviation 0.6908
|
-2.869 Log10 c/mL
Standard Deviation 0.6896
|
-2.745 Log10 c/mL
Standard Deviation 0.6602
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 24, n=52, 49, 48, 45
|
-2.700 Log10 c/mL
Standard Deviation 0.6261
|
-2.657 Log10 c/mL
Standard Deviation 0.6969
|
-2.853 Log10 c/mL
Standard Deviation 0.6889
|
-2.773 Log10 c/mL
Standard Deviation 0.7026
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 40, n=51, 48, 47, 44
|
-2.647 Log10 c/mL
Standard Deviation 0.7039
|
-2.665 Log10 c/mL
Standard Deviation 0.7051
|
-2.855 Log10 c/mL
Standard Deviation 0.6934
|
-2.795 Log10 c/mL
Standard Deviation 0.7169
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 48, n=51, 48, 48, 45
|
-2.723 Log10 c/mL
Standard Deviation 0.6519
|
-2.667 Log10 c/mL
Standard Deviation 0.6934
|
-2.850 Log10 c/mL
Standard Deviation 0.6849
|
-2.711 Log10 c/mL
Standard Deviation 0.7765
|
—
|
|
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Week 96, n=48, 44, 46, 39
|
-2.728 Log10 c/mL
Standard Deviation 0.6494
|
-2.680 Log10 c/mL
Standard Deviation 0.7116
|
-2.854 Log10 c/mL
Standard Deviation 0.7061
|
-2.807 Log10 c/mL
Standard Deviation 0.7238
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96Population: ITT-E Population.
Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 1, n=53, 50, 48, 50
|
85.0 Cells per cubic millimeter
Interval 18.0 to 134.0
|
94.5 Cells per cubic millimeter
Interval 40.0 to 160.0
|
75.5 Cells per cubic millimeter
Interval 18.5 to 129.5
|
42.5 Cells per cubic millimeter
Interval -23.0 to 111.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 12, n=53, 48, 48, 45
|
139.0 Cells per cubic millimeter
Interval 96.0 to 284.0
|
137.5 Cells per cubic millimeter
Interval 61.0 to 250.0
|
171.5 Cells per cubic millimeter
Interval 107.5 to 269.0
|
127.0 Cells per cubic millimeter
Interval 58.0 to 186.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 16, n=52, 49, 49, 44
|
153.0 Cells per cubic millimeter
Interval 95.0 to 276.0
|
176.0 Cells per cubic millimeter
Interval 86.0 to 227.0
|
160.0 Cells per cubic millimeter
Interval 94.0 to 227.0
|
115.5 Cells per cubic millimeter
Interval 65.5 to 226.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 20, n=52, 48, 49, 44
|
163.5 Cells per cubic millimeter
Interval 79.5 to 288.5
|
200.0 Cells per cubic millimeter
Interval 103.0 to 316.5
|
139.0 Cells per cubic millimeter
Interval 64.0 to 238.0
|
136.0 Cells per cubic millimeter
Interval 54.5 to 215.5
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 32, n=50, 48, 47, 44
|
221.5 Cells per cubic millimeter
Interval 94.0 to 300.0
|
195.5 Cells per cubic millimeter
Interval 109.0 to 294.0
|
203.0 Cells per cubic millimeter
Interval 125.0 to 282.0
|
146.5 Cells per cubic millimeter
Interval 82.5 to 223.5
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 40, n=50, 48, 47, 44
|
205.0 Cells per cubic millimeter
Interval 136.0 to 364.0
|
204.5 Cells per cubic millimeter
Interval 157.5 to 346.5
|
224.0 Cells per cubic millimeter
Interval 123.0 to 322.0
|
171.5 Cells per cubic millimeter
Interval 123.0 to 268.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 48, n=51, 47, 47, 45
|
204.0 Cells per cubic millimeter
Interval 127.0 to 384.0
|
249.0 Cells per cubic millimeter
Interval 143.0 to 416.0
|
223.0 Cells per cubic millimeter
Interval 141.0 to 292.0
|
174.0 Cells per cubic millimeter
Interval 91.0 to 292.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 84, n=51, 47, 46, 42
|
292.0 Cells per cubic millimeter
Interval 222.0 to 408.0
|
313.0 Cells per cubic millimeter
Interval 244.0 to 366.0
|
280.0 Cells per cubic millimeter
Interval 197.0 to 379.0
|
296.5 Cells per cubic millimeter
Interval 187.0 to 400.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 96, n=48, 44, 46, 39
|
335.0 Cells per cubic millimeter
Interval 253.5 to 478.5
|
391.5 Cells per cubic millimeter
Interval 243.0 to 527.0
|
326.0 Cells per cubic millimeter
Interval 236.0 to 451.0
|
301.0 Cells per cubic millimeter
Interval 204.0 to 445.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 2, n=53, 50, 50, 47
|
75.0 Cells per cubic millimeter
Interval 37.0 to 124.0
|
79.0 Cells per cubic millimeter
Interval 27.0 to 138.0
|
99.5 Cells per cubic millimeter
Interval 53.0 to 160.0
|
55.0 Cells per cubic millimeter
Interval -10.0 to 132.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 4, n=53, 50, 50, 45
|
75.0 Cells per cubic millimeter
Interval 34.0 to 151.0
|
89.0 Cells per cubic millimeter
Interval 36.0 to 165.0
|
110.0 Cells per cubic millimeter
Interval 46.0 to 170.0
|
89.0 Cells per cubic millimeter
Interval 30.0 to 165.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 8, n=52, 50, 49, 44
|
118.5 Cells per cubic millimeter
Interval 65.5 to 210.5
|
156.5 Cells per cubic millimeter
Interval 93.0 to 226.0
|
129.0 Cells per cubic millimeter
Interval 105.0 to 201.0
|
104.5 Cells per cubic millimeter
Interval 34.5 to 240.5
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 24, n=51, 49, 47, 44
|
159.0 Cells per cubic millimeter
Interval 97.0 to 233.0
|
206.0 Cells per cubic millimeter
Interval 102.0 to 289.0
|
167.0 Cells per cubic millimeter
Interval 125.0 to 268.0
|
109.5 Cells per cubic millimeter
Interval 66.0 to 229.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 60, n=51, 48, 47, 43
|
265.0 Cells per cubic millimeter
Interval 173.0 to 365.0
|
278.0 Cells per cubic millimeter
Interval 198.5 to 369.5
|
229.0 Cells per cubic millimeter
Interval 166.0 to 306.0
|
221.0 Cells per cubic millimeter
Interval 153.0 to 355.0
|
—
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Week 72, n=51, 47, 48, 44
|
236.0 Cells per cubic millimeter
Interval 177.0 to 351.0
|
285.0 Cells per cubic millimeter
Interval 186.0 to 427.0
|
220.0 Cells per cubic millimeter
Interval 146.0 to 373.0
|
195.0 Cells per cubic millimeter
Interval 144.0 to 334.5
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96Population: ITT-E Population
HIV-associated conditions were assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the acquired immunodeficiency syndrome (AIDS) surveillance case definition.
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With New HIV-associated Conditions of the Indicated Class
Category B
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With New HIV-associated Conditions of the Indicated Class
Category C
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With New HIV-associated Conditions of the Indicated Class
Death
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96Population: ITT-E Population
Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CAT A at Baseline (BS) to CAT B event (EV), CAT A at BS to a CAT C EV; CAT B at BS to a CAT C EV; CAT C at BS to a new CAT C EV; or CAT A, B, or C at BS to death.
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)
CAT A at Baseline to a CAT C event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)
CAT B at Baseline to a CAT C event
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)
CAT C at Baseline to a new CAT C event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)
CAT A, B, or C at Baseline to death
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96Population: ITT-E Population
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (\<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 1
|
6 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 2
|
22 Participants
|
19 Participants
|
11 Participants
|
6 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 20
|
51 Participants
|
47 Participants
|
47 Participants
|
38 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 24
|
51 Participants
|
46 Participants
|
47 Participants
|
41 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 72
|
48 Participants
|
44 Participants
|
45 Participants
|
40 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 4
|
37 Participants
|
35 Participants
|
31 Participants
|
9 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 8
|
46 Participants
|
45 Participants
|
43 Participants
|
18 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 12
|
50 Participants
|
46 Participants
|
45 Participants
|
25 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 16
|
51 Participants
|
46 Participants
|
47 Participants
|
29 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 32
|
50 Participants
|
45 Participants
|
46 Participants
|
43 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 40
|
49 Participants
|
45 Participants
|
46 Participants
|
42 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 48
|
48 Participants
|
45 Participants
|
46 Participants
|
40 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 60
|
48 Participants
|
44 Participants
|
46 Participants
|
41 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 84
|
47 Participants
|
43 Participants
|
46 Participants
|
38 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Week 96
|
42 Participants
|
40 Participants
|
45 Participants
|
36 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96Population: ITT-E Population
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (\<400 c/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 1
|
25 Participants
|
20 Participants
|
16 Participants
|
15 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 2
|
45 Participants
|
45 Participants
|
41 Participants
|
23 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 4
|
52 Participants
|
49 Participants
|
48 Participants
|
32 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 20
|
52 Participants
|
48 Participants
|
49 Participants
|
45 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 48
|
50 Participants
|
47 Participants
|
48 Participants
|
44 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 8
|
52 Participants
|
49 Participants
|
49 Participants
|
41 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 12
|
52 Participants
|
49 Participants
|
49 Participants
|
45 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 16
|
52 Participants
|
48 Participants
|
49 Participants
|
45 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 24
|
52 Participants
|
47 Participants
|
48 Participants
|
45 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 32
|
52 Participants
|
47 Participants
|
48 Participants
|
45 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 40
|
50 Participants
|
47 Participants
|
48 Participants
|
45 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 60
|
50 Participants
|
46 Participants
|
48 Participants
|
44 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 72
|
50 Participants
|
46 Participants
|
47 Participants
|
43 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 84
|
50 Participants
|
45 Participants
|
47 Participants
|
42 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Week 96
|
46 Participants
|
43 Participants
|
46 Participants
|
39 Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96/Early WithdrawalPopulation: Safety Population:All participants who received at least one dose of the study medication
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. All clinically suspected cases of hypersensitivity reaction to abacavir in participants receiving abacavir/lamivudine were reported as SAEs. Medical or scientific judgment was to have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold \>=3%) and SAEs.
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)
Any AE
|
50 Participants
|
46 Participants
|
46 Participants
|
46 Participants
|
—
|
|
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)
Any SAE
|
5 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96/Early WithdrawalPopulation: Safety Population
Blood samples were collected for the measurement of clinical chemistry and hematology parameters. Toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Outcome measures
| Measure |
DTG 10 mg QD
n=53 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=51 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=51 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=50 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Cholesterol
|
18 Participants
|
16 Participants
|
13 Participants
|
24 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Creatinine kinase
|
17 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Triglycerides
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Alkaline phosphatase
|
1 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Hypercalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Hyperglycaemia
|
16 Participants
|
15 Participants
|
17 Participants
|
17 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Hyperkalemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Hypernatremia
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Hypocalcemia
|
4 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Hypoglycaemia
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Hyponatremia
|
6 Participants
|
12 Participants
|
7 Participants
|
13 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Low-density lipoprotein cholesterol
|
14 Participants
|
15 Participants
|
11 Participants
|
20 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Activated partial thromboplastin time
|
7 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
International normalized ratio
|
6 Participants
|
9 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Platelet count
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Prothrombin time
|
7 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Total neutrophils
|
9 Participants
|
7 Participants
|
6 Participants
|
10 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
White blood cell count
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Alanine amino transferase
|
7 Participants
|
11 Participants
|
3 Participants
|
19 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Lipase
|
11 Participants
|
13 Participants
|
11 Participants
|
9 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Amylase
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Aspartate amino transferase
|
12 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Carbon dioxide content/bicarbonate
|
28 Participants
|
24 Participants
|
23 Participants
|
30 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Creatinine
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Hypokalemia
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Magnesium
|
7 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Phosphate, inorganic
|
9 Participants
|
15 Participants
|
14 Participants
|
11 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Total bilirubin
|
3 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Hemoglobin
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96/Early WithdrawalPopulation: On-treatment Genotypic Resistance Population.
For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \<1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>=400 copies/mL on or after Week 24 without evidence of prior suppression to \<400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \>=400 copies/mL after prior confirmed suppression to \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value \>=400 copies/mL.On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.
Outcome measures
| Measure |
DTG 10 mg QD
n=2 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=1 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=1 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
A23A/V
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
S255N
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96/Early WithdrawalPopulation: On-treatment Genotypic Resistance Population
For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \<1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>=400 copies/mL on or after Week 24 without evidence of prior suppression to \<400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \>=400 copies/mL after prior confirmed suppression to \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value \>=400 copies/mL.
Outcome measures
| Measure |
DTG 10 mg QD
n=2 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=1 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
n=1 Participants
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to Week 96/Early WithdrawalPopulation: On-treatment Phenotypic Resistance Population
The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. Fold increase in DTG FC at the time of PDVF was derived as the PDVF FC/Baseline FC ratio. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \<1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>=400 copies/mL on or after Week 24 without evidence of prior suppression to \<400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \>=400 copies/mL after prior confirmed suppression to \<400 copies/mL; confirmed plasma HIV-1 RNA levels \>0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value \>=400 copies/mL.On-treatment Phenotypic Resistance Population: all participants in the ITT-E Population with available on-treatment phenotypic data
Outcome measures
| Measure |
DTG 10 mg QD
n=2 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=1 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
1-<2 fold
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
4-<8 fold
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
>=8 fold
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
<1 fold
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
2-<4 fold
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2, Week 12, and Week 24Population: PK Summary Population.
Blood samples for the determination of plasma DTG concentration were collected from the participants randomized to receive DTG, at the following time points: pre-dose and 2-4 hours post-dose at Weeks 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. The Pharmacokinetic (PK) Summary Population is comprised of all participants who received DTG and underwent intensive PK sampling or limited PK sampling during the study and provided evaluable DTG PK parameters. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles).Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.
Outcome measures
| Measure |
DTG 10 mg QD
n=48 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=46 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=46 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Plasma DTG Concentration
Week 2, Pre-dose, n=46, 44, 43, 0
|
0.3580 Micrograms per milliliter (µg/mL)
Standard Deviation 0.18321
|
0.6779 Micrograms per milliliter (µg/mL)
Standard Deviation 0.44085
|
1.4044 Micrograms per milliliter (µg/mL)
Standard Deviation 0.88041
|
—
|
—
|
|
Plasma DTG Concentration
Week 2, 2-4 hours post-dose, n=31, 29, 29, 0
|
1.0121 Micrograms per milliliter (µg/mL)
Standard Deviation 0.28125
|
1.9716 Micrograms per milliliter (µg/mL)
Standard Deviation 0.71890
|
3.8414 Micrograms per milliliter (µg/mL)
Standard Deviation 1.87405
|
—
|
—
|
|
Plasma DTG Concentration
Week 24, Pre-dose, n=45, 44, 44, 0
|
0.3766 Micrograms per milliliter (µg/mL)
Standard Deviation 0.23399
|
0.6636 Micrograms per milliliter (µg/mL)
Standard Deviation 0.50767
|
1.4534 Micrograms per milliliter (µg/mL)
Standard Deviation 0.94283
|
—
|
—
|
|
Plasma DTG Concentration
Week 24, 2-4 hours post-dose, n=45, 45, 45, 0
|
1.0113 Micrograms per milliliter (µg/mL)
Standard Deviation 0.34083
|
1.9021 Micrograms per milliliter (µg/mL)
Standard Deviation 0.79430
|
3.5397 Micrograms per milliliter (µg/mL)
Standard Deviation 1.36538
|
—
|
—
|
|
Plasma DTG Concentration
Week 12, Pre-dose, n= 46, 45, 44, 0
|
0.3648 Micrograms per milliliter (µg/mL)
Standard Deviation 0.16791
|
0.5759 Micrograms per milliliter (µg/mL)
Standard Deviation 0.32645
|
1.4169 Micrograms per milliliter (µg/mL)
Standard Deviation 1.00152
|
—
|
—
|
|
Plasma DTG Concentration
Week 12, 2-4 hours post-dose, n=48, 45, 45, 0
|
1.0374 Micrograms per milliliter (µg/mL)
Standard Deviation 0.27517
|
1.7907 Micrograms per milliliter (µg/mL)
Standard Deviation 0.70953
|
3.6056 Micrograms per milliliter (µg/mL)
Standard Deviation 1.33862
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2Population: PK Summary Population.
The area under the time concentration curve over the dosing interval (AUC\[0-tau\]) of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed.
Outcome measures
| Measure |
DTG 10 mg QD
n=15 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=15 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=15 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
AUC(0-tau) of DTG
|
16.0 Hours*µg/mL
Geometric Coefficient of Variation 40
|
23.1 Hours*µg/mL
Geometric Coefficient of Variation 48
|
48.1 Hours*µg/mL
Geometric Coefficient of Variation 40
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2Population: PK Summary Population. Only those participants available at the specified time points were analyzed.
The Cmax, Cmax, and Ctau of DTG were determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Outcome measures
| Measure |
DTG 10 mg QD
n=15 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=15 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=15 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Maximal Concentration (Cmax), Minimal Concentration (Cmin), and Concentration at the End of Dosing Interval (Ctau) of DTG
Cmax
|
1.10 µg/mL
Geometric Coefficient of Variation 37
|
1.71 µg/mL
Geometric Coefficient of Variation 43
|
3.40 µg/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
|
Maximal Concentration (Cmax), Minimal Concentration (Cmin), and Concentration at the End of Dosing Interval (Ctau) of DTG
Ctau
|
0.37 µg/mL
Geometric Coefficient of Variation 55
|
0.45 µg/mL
Geometric Coefficient of Variation 71
|
1.05 µg/mL
Geometric Coefficient of Variation 72
|
—
|
—
|
|
Maximal Concentration (Cmax), Minimal Concentration (Cmin), and Concentration at the End of Dosing Interval (Ctau) of DTG
Cmin
|
0.33 µg/mL
Geometric Coefficient of Variation 64
|
0.44 µg/mL
Geometric Coefficient of Variation 68
|
0.94 µg/mL
Geometric Coefficient of Variation 74
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2, Week 12, and Week 24Population: PK Summary Population.
The plasma DTG C0 of DTG was determined using limited/sparse PK sampling at Week 2, Week 12, and Week 24. C0 avg was calculated at Week 24 as the mean of the C0 of DTG at Week 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.
Outcome measures
| Measure |
DTG 10 mg QD
n=49 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=46 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=46 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Pre-dose Concentration (C0) and C0 Avg of DTG
C0, Week 2, n=46, 44, 43, 0
|
0.31 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 58
|
0.57 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 62
|
1.20 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 61
|
—
|
—
|
|
Pre-dose Concentration (C0) and C0 Avg of DTG
C0, Week 12, n=46, 45, 44, 0
|
0.33 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 49
|
0.47 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 77
|
1.13 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 95
|
—
|
—
|
|
Pre-dose Concentration (C0) and C0 Avg of DTG
C0, Week 24, n=45, 44, 44, 0
|
0.33 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 67
|
0.57 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 74
|
1.20 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 74
|
—
|
—
|
|
Pre-dose Concentration (C0) and C0 Avg of DTG
C0 avg, n=48, 46, 46, 0
|
0.34 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 49
|
0.56 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 61
|
1.25 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 55
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2Population: PK Summary Population. Only those participants available at the specified time points were analyzed.
Tmax of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Outcome measures
| Measure |
DTG 10 mg QD
n=15 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=15 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=15 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Time to Maximal Drug Concentration (Tmax) of DTG
|
2.0 Hours
Interval 2.0 to 4.0
|
2.0 Hours
Interval 2.0 to 8.0
|
2.0 Hours
Interval 1.9 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2Population: PK/PD Analysis Population.Only those participants available at the specified time points were analyzed.
Relationships between Week 2 plasma DTG PK parameters (AUC\[0-tau\] \[area under the time concentration curve over the dosing interval\], Cmax \[maximal concentration\], and Ctau \[concentration at the end of the dosing interval\]) and the change from Baseline in plasma HIV-1 RNA at Week 2 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between plasma HIV-1 RNA and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. PK/Pharmacodynamic (PD) Analysis Population: all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable DTG plasma concentration data considered suitable for investigation of relationship with the PD measures
Outcome measures
| Measure |
DTG 10 mg QD
n=15 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=15 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=15 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
n=45 Participants
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters
AUC(0-tau)
|
0.426 Pearson's correlation coefficient
|
-0.018 Pearson's correlation coefficient
|
-0.258 Pearson's correlation coefficient
|
—
|
-0.086 Pearson's correlation coefficient
|
|
Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters
Cmax
|
0.452 Pearson's correlation coefficient
|
-0.051 Pearson's correlation coefficient
|
-0.150 Pearson's correlation coefficient
|
—
|
-0.055 Pearson's correlation coefficient
|
|
Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters
Ctau
|
0.273 Pearson's correlation coefficient
|
-0.100 Pearson's correlation coefficient
|
-0.263 Pearson's correlation coefficient
|
—
|
-0.129 Pearson's correlation coefficient
|
SECONDARY outcome
Timeframe: Week 96Population: PK/PD Analysis Population.
Relationships between plasma DTG PK parameters (AUC\[0-tau\] \[area under the time concentration curve over the dosing interval\], Cmax \[maximal concentration\], C0avg \[average pre-dose concentration\], and Ctau \[concentration at the end of the dosing interval\]) and the change from Baseline in CD4+ cell counts at Week 96 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between CD4+ cell counts and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association.Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Outcome measures
| Measure |
DTG 10 mg QD
n=50 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
n=46 Participants
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
n=46 Participants
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
n=142 Participants
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau), n=13, 14, 15, 0
|
-0.100 Pearson's correlation coefficient
|
0.379 Pearson's correlation coefficient
|
0.008 Pearson's correlation coefficient
|
—
|
-0.005 Pearson's correlation coefficient
|
|
Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax, n=13, 14, 15, 0
|
-0.047 Pearson's correlation coefficient
|
0.332 Pearson's correlation coefficient
|
0.234 Pearson's correlation coefficient
|
—
|
0.037 Pearson's correlation coefficient
|
|
Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg, n=43, 40, 42, 0
|
-0.009 Pearson's correlation coefficient
|
-0.013 Pearson's correlation coefficient
|
0.206 Pearson's correlation coefficient
|
—
|
-0.011 Pearson's correlation coefficient
|
|
Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau, n=13, 14, 15, 0
|
-0.289 Pearson's correlation coefficient
|
0.299 Pearson's correlation coefficient
|
-0.074 Pearson's correlation coefficient
|
—
|
-0.055 Pearson's correlation coefficient
|
SECONDARY outcome
Timeframe: Week 96Population: PK/PD Analysis Population.Only those participants available at the specified time points were analyzed
Relationships between log-transformed plasma DTG PK parameters (AUC\[0-tau\], Cmax, C0, C0avg, Ctau, and Cmin) and safety parameters (AE occurrence, maximum AE intensity, alanine aminotransferase \[ALT\], change from Baseline \[CFB\] in ALT, total bilirubin, CFB in total bilirubin, creatine kinase, CFB in creatine kinase, triglycerides, CFB in triglycerides, lipase, CFB in lipase, total cholesterol \[TC\], CFB in TC) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between safety parameters and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. The presence of \>=1 AE was used for AE occurrence. The most severe AE grade/intensity was used for maximum AE intensity. Maximum laboratory values per participant were used for safety parameters. CFB was calculated as the post-Baseline value minus the value at Baseline.
Outcome measures
| Measure |
DTG 10 mg QD
n=142 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus CFB in triglycerides, n=45
|
0.244 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus AE occurrence, n=45
|
0.114 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus maximum AE intensity, n=45
|
0.171 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus ALT, n=45
|
-0.196 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus CFB in ALT, n=45
|
-0.201 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus total bilirubin, n=45
|
0.364 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus CFB in total bilirubin, n=45
|
0.147 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus creatine kinase, n=45
|
-0.168 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus CFB in creatine kinase, n=45
|
-0.145 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) vs Triglycerides, n=45
|
0.104 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus CFB in triglycerides, n=45
|
0.216 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus lipase, n=45
|
-0.066 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus CFB in lipase, n=45
|
0.092 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus total cholesterol, n=45
|
-0.097 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
AUC(0-tau) versus CFB in total cholesterol, n=45
|
-0.153 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus AE occurrence, n=45
|
0.061 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus maximum AE intensity, n=45
|
0.110 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus ALT, n=45
|
-0.135 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus CFB in ALT, n=45
|
-0.135 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus total bilirubin, n=45
|
0.265 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus CFB in total bilirubin, n=45
|
0.033 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus creatine kinase, n=45
|
-0.188 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus CFB in creatine kinase, n=45
|
-0.161 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus triglycerides, n=45
|
0.134 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus lipase, n=45
|
-0.034 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus CFB in lipase, n=45
|
0.115 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus total cholesterol, n=45
|
-0.101 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmax versus CFB in total cholesterol, n=45
|
-0.192 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus AE occurrence, n=133
|
-0.080 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus maximum AE intensity, n=133
|
-0.003 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus ALT, n=133
|
-0.196 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus CFB in ALT, n=133
|
-0.237 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus total bilirubin, n=133
|
0.298 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus CFB in total bilirubin, n=133
|
0.120 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus creatine kinase, n=133
|
-0.094 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus CFB in creatine kinase, n=133
|
-0.093 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus triglycerides, n=133
|
-0.058 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus CFB in triglycerides, n=133
|
-0.012 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus lipase, n=133
|
-0.187 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus CFB in lipase, n=133
|
-0.137 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus total cholesterol, n=133
|
-0.179 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0 versus CFB in total cholesterol, n=133
|
-0.125 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus AE occurrence, n=140
|
-0.028 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus maximum AE intensity, n=140
|
0.036 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus ALT, n=140
|
-0.166 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus CFB in ALT, n=140
|
-0.177 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus total bilirubin, n=140
|
0.319 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus CFB in total bilirubin, n=140
|
0.109 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus creatine kinase, n=140
|
-0.114 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus CFB in creatine kinase, n=140
|
-0.110 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus triglycerides, n=140
|
0.057 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus CFB in triglycerides, n=140
|
0.092 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus lipase, n=140
|
-0.164 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus CFB in lipase, n=140
|
-0.120 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus total cholesterol, n=140
|
-0.170 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
C0avg versus CFB in total cholesterol, n=140
|
-0.083 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus AE occurrence, n=45
|
0.190 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus maximum AE intensity, n=45
|
0.205 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus ALT, n=45
|
-0.281 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus CFB in ALT, n=45
|
-0.285 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus total bilirubin, n=45
|
0.446 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus CFB in total bilirubin, n=45
|
0.237 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus creatine kinase, n=45
|
-0.143 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus CFB in creatine kinase, n=45
|
-0.125 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus triglycerides, n=45
|
0.061 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus CFB in triglycerides, n=45
|
0.172 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus lipase, n=45
|
-0.131 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus CFB in lipase, n=45
|
0.056 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus total cholesterol, n=45
|
-0.039 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Ctau versus CFB in total cholesterol, n=45
|
-0.108 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus AE occurrence, n=45
|
0.156 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus maximum AE intensity, n=45
|
0.193 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus ALT, n=45
|
-0.236 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus CFB in ALT, n=45
|
-0.253 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus total bilirubin, n=45
|
0.430 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus CFB in total bilirubin, n=45
|
0.171 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus creatine kinase, n=45
|
-0.132 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus CFB in creatine kinase, n=45
|
-0.124 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus triglycerides, n=45
|
-0.042 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus CFB in triglycerides, n=45
|
0.057 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus lipase, n=45
|
-0.135 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus CFB in lipase, n=45
|
0.032 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus total cholesterol, n=45
|
-0.194 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
|
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Cmin versus CFB in total cholesterol, n=45
|
-0.208 Pearson's correlation coefficient
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 96Population: PK/PD Analysis Population.
Logistic regressions were performed to examine the correlation between plasma DTG PK parameters (AUC\[0-tau\] \[area under the time concentration curve over the dosing interval\], Cmax \[maximal concentration\], Ctau \[concentration at the end of the dosing interval\], and C0avg \[average pre-dose concentration\]) on log scales and the presence of gastrointestinal system organ class AEs (abdominal pain, diarrhea, nausea, and vomiting) at Week 96. Data are presented as estimates from logistic regression, which is a measure of the association between AEs of special interest and plasma DTG PK parameters. A value of 0 indicates no statistical association; a large absolute value of the estimate indicates higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Results are presented for participants in any DTG group (overall DTG).Only those participants available at the specified time points were analyzed represented by n=X in the category titles
Outcome measures
| Measure |
DTG 10 mg QD
n=142 Participants
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
|
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
|
|---|---|---|---|---|---|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Vomiting versus Cmax, n=45
|
-1.61 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Abdominal pain versus AUC(0-tau), n=45
|
-2.49 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Abdominal pain versus Cmax, n=45
|
-2.98 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Abdominal pain versus Ctau, n=45
|
-1.72 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Abdominal pain versus C0avg, n=140
|
-0.41 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Diarrhoea versus AUC(0-tau), n=45
|
-0.62 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Diarrhoea versus Cmax, n=45
|
-0.98 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Diarrhoea versus Ctau, n=45
|
-0.29 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Diarrhoea versus C0avg, n=140
|
0.13 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Nausea versus AUC(0-tau), n=45
|
-0.31 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Nausea versus Cmax, n=45
|
-0.72 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Nausea versus Ctau, n=45
|
0.03 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Nausea versus C0avg, n=140
|
-0.32 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Vomiting versus AUC(0-tau), n=45
|
-1.29 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Vomiting versus Ctau, n=45
|
-1.15 estimated effect
|
—
|
—
|
—
|
—
|
|
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Vomiting versus C0avg, n=140
|
-0.89 estimated effect
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96Population: ITT-E Population
Change from Baseline in CD8+ cell count data are not available; CD8+ data are only listed on a per-participant basis and were not summarized.
Outcome measures
Outcome data not reported
Adverse Events
DTG 10mg QD
Serious events: 6 serious events
Other events: 49 other events
Deaths: 2 deaths
DTG 25mg QD
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
DTG 50mg QD
Serious events: 7 serious events
Other events: 45 other events
Deaths: 0 deaths
EFV 600mg
Serious events: 7 serious events
Other events: 46 other events
Deaths: 0 deaths
Open-label DTG 50 mg QD
Serious events: 16 serious events
Other events: 112 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
DTG 10mg QD
n=53 participants at risk
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 25mg QD
n=51 participants at risk
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50mg QD
n=51 participants at risk
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600mg
n=50 participants at risk
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Open-label DTG 50 mg QD
n=138 participants at risk
All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
|
|---|---|---|---|---|---|
|
Product Issues
Device malfunction
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Abscess
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Lipomatosis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Meningitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Primary syphilis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Seizure
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
DTG 10mg QD
n=53 participants at risk
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 25mg QD
n=51 participants at risk
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
DTG 50mg QD
n=51 participants at risk
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
EFV 600mg
n=50 participants at risk
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
|
Open-label DTG 50 mg QD
n=138 participants at risk
All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Breast mass
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Genital lesion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
3/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Bradycardia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
13.2%
7/53 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
13.7%
7/51 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
11.8%
6/51 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
10.0%
5/50 • Number of events 7 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
14.5%
20/138 • Number of events 27 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
6/53 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
17.6%
9/51 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
13.7%
7/51 • Number of events 8 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
10.0%
5/50 • Number of events 7 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
8.7%
12/138 • Number of events 14 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
18.9%
10/53 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
15.7%
8/51 • Number of events 9 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
11.8%
6/51 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
14.0%
7/50 • Number of events 7 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
13.2%
7/53 • Number of events 9 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
11.8%
6/51 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
15.7%
8/51 • Number of events 12 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
6.0%
3/50 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.8%
8/138 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
5/53 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
7.8%
4/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
11.8%
6/51 • Number of events 8 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
7.2%
10/138 • Number of events 12 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
9.4%
5/53 • Number of events 7 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
10.0%
5/50 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
7.2%
10/138 • Number of events 14 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
13.7%
7/51 • Number of events 7 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
11.8%
6/51 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
12.0%
6/50 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.6%
5/138 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
9.4%
5/53 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
9.8%
5/51 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
7.8%
4/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
6.0%
3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.3%
6/138 • Number of events 9 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
5.7%
3/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
11.8%
6/51 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
10.0%
5/50 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.3%
6/138 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
3/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
8.0%
4/50 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
7.2%
10/138 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
22.0%
11/50 • Number of events 13 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Syphilis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
8.0%
4/50 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
8.7%
12/138 • Number of events 15 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
9.4%
5/53 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
7.8%
4/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
8.0%
4/50 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.3%
6/138 • Number of events 9 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
7.5%
4/53 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
6.0%
3/50 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
6.5%
9/138 • Number of events 13 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
11.8%
6/51 • Number of events 8 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.1%
7/138 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
5/53 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
12.0%
6/50 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
7.8%
4/51 • Number of events 7 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
12.0%
6/50 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
3.8%
2/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
8.0%
4/50 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.3%
6/138 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
6.0%
3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
4/138 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.6%
5/138 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.8%
8/138 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
3/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.6%
5/138 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
5.7%
3/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
3/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Asthenia
|
7.5%
4/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
4/53 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.6%
5/138 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
6.0%
3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.6%
5/138 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
5.7%
3/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Rhinitis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.6%
5/138 • Number of events 7 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tonsillitis
|
5.7%
3/53 • Number of events 10 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Influenza like illness
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Oral herpes
|
7.5%
4/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection viral
|
5.7%
3/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
4/138 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Abnormal dreams
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
6.0%
3/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Chest pain
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
4/138 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Herpes simplex
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tooth abscess
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
3.8%
2/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/53 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Fungal skin infection
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
7.8%
4/51 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Proctitis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
5.9%
3/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Chlamydial infection
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Ear infection
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Faeces soft
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Furuncle
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Malaise
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
8.0%
4/50 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Otitis media
|
5.7%
3/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Stress
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
4/138 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urethritis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Haematochezia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Herpes virus infection
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Endocrine disorders
Hypogonadism
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.2%
3/138 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Memory impairment
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tinea pedis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Angular cheilitis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.9%
1/53 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bacteriuria
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Blood glucose increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Body tinea
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
2/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Cystitis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Dermatophytosis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Fungal infection
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperinsulinaemia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Leukocyturia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Lipase increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Papilloma viral infection
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Poor quality sleep
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Prostatitis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
3.9%
2/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.9%
1/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Shigella infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
1.4%
2/138 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Acute hepatitis C
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Amylase increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Anal infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Anal injury
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Anal pap smear abnormal
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal pruritus
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal sphincter hypertonia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Ankle impingement
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anorectal disorder
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anorectal ulcer
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Arterial fibrosis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Astigmatism
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Bacterial test positive
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Bulimia nervosa
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Candida infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Cardiac murmur
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Chalazion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Dark circles under eyes
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Drug intolerance
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Endometritis
|
1.9%
1/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Enterocolitis viral
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Face injury
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Fat redistribution
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Feeling drunk
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Feeling hot
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Food allergy
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis shigella
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
General physical health deterioration
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Genitourinary chlamydia infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gingivitis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Endocrine disorders
Goitre
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hot flush
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Impetigo
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected naevus
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Injection site pain
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Leukoplakia oral
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Libido increased
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Lipoatrophy
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Listless
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Liver function test increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Lymphogranuloma venereum
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Migraine
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Multiple allergies
|
1.9%
1/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Myopia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Nodule
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
General disorders
Oedema
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Pancreatic atrophy
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Paronychia
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Periodontitis
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Urinary sediment present
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Presbyacusis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Primary syphilis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Proctitis gonococcal
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Rubella
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Skin candida
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Substance use disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tinea infection
|
1.9%
1/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Tongue biting
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Toxocariasis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Transaminases increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Tremor
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Urethral discharge
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urethritis gonococcal
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Urethritis noninfective
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.9%
1/53 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Vision blurred
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Vitreous floaters
|
1.9%
1/53 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Weight decreased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/51 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Investigations
Weight increased
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/138 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/53 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/50 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
0.72%
1/138 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
|
Additional Information
GSK Response Center
ViiV Healthcare
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER