Trial Outcomes & Findings for The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP) (NCT NCT01327651)
NCT ID: NCT01327651
Last Updated: 2025-03-27
Results Overview
Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
622 participants
Primary outcome timeframe
From week 6 (randomization week) to week 30 (end of self-administered dosing)
Results posted on
2025-03-27
Participant Flow
The study enrolled men, and transgender women, who have sex with men at a community clinic and clinical research site (CRS) in Bangkok, Thailand, and a CRS in Harlem in New York City, USA. Women were enrolled at a study site in Cape Town, South Africa. The last participant was enrolled in May of 2014
Of the 902 screened participants, 622 were eligible to be enrolled into the study, and participated in a 6-week lead-in period of directly observed dosing (DOD) of one tablet once-weekly of FTC/TDF for five observed doses followed by 1-week off drug. 86% (N=536) completed the lead-in period and were randomized to the three arms.
Participant milestones
| Measure |
Daily Dosing, Cape Town
Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors
|
Event-driven Dosing, Bangkok
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
|---|---|---|---|---|---|---|---|---|---|
|
Self-administered Dosing Period
STARTED
|
60
|
59
|
60
|
60
|
59
|
59
|
59
|
60
|
60
|
|
Self-administered Dosing Period
Week 10
|
59
|
58
|
60
|
60
|
59
|
59
|
57
|
57
|
56
|
|
Self-administered Dosing Period
Week 14
|
59
|
55
|
57
|
60
|
58
|
59
|
54
|
51
|
54
|
|
Self-administered Dosing Period
Week 18
|
57
|
56
|
56
|
60
|
57
|
59
|
53
|
49
|
53
|
|
Self-administered Dosing Period
Week 22
|
59
|
56
|
55
|
58
|
56
|
59
|
50
|
50
|
51
|
|
Self-administered Dosing Period
Week 26
|
58
|
56
|
53
|
57
|
56
|
58
|
50
|
51
|
49
|
|
Self-administered Dosing Period
COMPLETED
|
56
|
56
|
56
|
57
|
56
|
59
|
49
|
50
|
49
|
|
Self-administered Dosing Period
NOT COMPLETED
|
4
|
3
|
4
|
3
|
3
|
0
|
10
|
10
|
11
|
|
Post Study Follow-up
STARTED
|
56
|
56
|
56
|
57
|
56
|
59
|
49
|
50
|
49
|
|
Post Study Follow-up
COMPLETED
|
56
|
55
|
55
|
57
|
56
|
59
|
45
|
49
|
47
|
|
Post Study Follow-up
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
0
|
4
|
1
|
2
|
Reasons for withdrawal
| Measure |
Daily Dosing, Cape Town
Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors
|
Event-driven Dosing, Bangkok
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
|---|---|---|---|---|---|---|---|---|---|
|
Self-administered Dosing Period
Lost to Follow-up
|
3
|
2
|
4
|
2
|
3
|
0
|
8
|
9
|
10
|
|
Self-administered Dosing Period
Ineligible (retrospective result)
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Self-administered Dosing Period
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
1
|
1
|
|
Post Study Follow-up
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
0
|
4
|
1
|
2
|
Baseline Characteristics
The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)
Baseline characteristics by cohort
| Measure |
Daily Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=60 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=60 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=59 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Total
n=535 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
26 years
n=7 Participants
|
25 years
n=5 Participants
|
31 years
n=4 Participants
|
28 years
n=21 Participants
|
31 years
n=10 Participants
|
28 years
n=115 Participants
|
31 years
n=6 Participants
|
32 years
n=6 Participants
|
29 years
n=64 Participants
|
|
Age, Customized
18-24 years
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
17 Participants
n=6 Participants
|
17 Participants
n=6 Participants
|
157 Participants
n=64 Participants
|
|
Age, Customized
25-29 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
117 Participants
n=64 Participants
|
|
Age, Customized
30-39 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
14 Participants
n=6 Participants
|
161 Participants
n=64 Participants
|
|
Age, Customized
40+ years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
20 Participants
n=6 Participants
|
21 Participants
n=6 Participants
|
100 Participants
n=64 Participants
|
|
Sex/Gender, Customized
Female
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
178 Participants
n=64 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
59 Participants
n=10 Participants
|
57 Participants
n=115 Participants
|
59 Participants
n=6 Participants
|
58 Participants
n=6 Participants
|
350 Participants
n=64 Participants
|
|
Sex/Gender, Customized
Transgender woman
|
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
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
|
Sex/Gender, Customized
Gender queer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
|
Education
Less than secondary
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
18 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
159 Participants
n=64 Participants
|
|
Education
Secondary and above
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
43 Participants
n=115 Participants
|
42 Participants
n=6 Participants
|
53 Participants
n=6 Participants
|
376 Participants
n=64 Participants
|
|
Number of sex partners in the past 3 months
|
1 sex partners
n=5 Participants
|
1 sex partners
n=7 Participants
|
1 sex partners
n=5 Participants
|
3 sex partners
n=4 Participants
|
3 sex partners
n=21 Participants
|
3 sex partners
n=10 Participants
|
3 sex partners
n=115 Participants
|
3 sex partners
n=6 Participants
|
4 sex partners
n=6 Participants
|
2 sex partners
n=64 Participants
|
|
Number of anal intercourse without a condom
|
2 anal intercourse
n=5 Participants
|
2 anal intercourse
n=7 Participants
|
1 anal intercourse
n=5 Participants
|
0 anal intercourse
n=4 Participants
|
0 anal intercourse
n=21 Participants
|
0 anal intercourse
n=10 Participants
|
3 anal intercourse
n=115 Participants
|
3 anal intercourse
n=6 Participants
|
5 anal intercourse
n=6 Participants
|
1 anal intercourse
n=64 Participants
|
PRIMARY outcome
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=1952 sexual exposures
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=1074 sexual exposures
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=1542 sexual exposures
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=1485 sexual exposures
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=1337 sexual exposures
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=1018 sexual exposures
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=1081 sexual exposures
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=1311 sexual exposures
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=1502 sexual exposures
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
% completely covered
|
75 percentage of sexual exposures
|
56 percentage of sexual exposures
|
52 percentage of sexual exposures
|
85 percentage of sexual exposures
|
84 percentage of sexual exposures
|
74 percentage of sexual exposures
|
66 percentage of sexual exposures
|
47 percentage of sexual exposures
|
52 percentage of sexual exposures
|
—
|
—
|
—
|
|
Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
% pre-exposure coverage
|
21 percentage of sexual exposures
|
30 percentage of sexual exposures
|
33 percentage of sexual exposures
|
11 percentage of sexual exposures
|
12 percentage of sexual exposures
|
19 percentage of sexual exposures
|
24 percentage of sexual exposures
|
30 percentage of sexual exposures
|
29 percentage of sexual exposures
|
—
|
—
|
—
|
|
Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
% post-exposure coverage
|
1 percentage of sexual exposures
|
9 percentage of sexual exposures
|
8 percentage of sexual exposures
|
1 percentage of sexual exposures
|
3 percentage of sexual exposures
|
5 percentage of sexual exposures
|
2 percentage of sexual exposures
|
8 percentage of sexual exposures
|
6 percentage of sexual exposures
|
—
|
—
|
—
|
|
Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
% uncovered
|
3 percentage of sexual exposures
|
5 percentage of sexual exposures
|
7 percentage of sexual exposures
|
3 percentage of sexual exposures
|
1 percentage of sexual exposures
|
3 percentage of sexual exposures
|
8 percentage of sexual exposures
|
15 percentage of sexual exposures
|
13 percentage of sexual exposures
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are "covered"; Note: sex act is considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=1952 sexual exposure
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=1074 sexual exposure
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=1542 sexual exposure
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=1485 sexual exposure
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=1337 sexual exposure
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=1018 sexual exposure
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=1081 sexual exposure
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=1311 sexual exposure
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=1502 sexual exposure
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)
|
2097 Number of pills needed for 100% coverage
|
1552 Number of pills needed for 100% coverage
|
1906 Number of pills needed for 100% coverage
|
1746 Number of pills needed for 100% coverage
|
1573 Number of pills needed for 100% coverage
|
1268 Number of pills needed for 100% coverage
|
1244 Number of pills needed for 100% coverage
|
1390 Number of pills needed for 100% coverage
|
1582 Number of pills needed for 100% coverage
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=60 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=60 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=59 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Total Pills Actually Used Over the Follow-up Period
|
7349 Number of pills actually used
|
2852 Number of pills actually used
|
2000 Number of pills actually used
|
8285 Number of pills actually used
|
3713 Number of pills actually used
|
2157 Number of pills actually used
|
5507 Number of pills actually used
|
2468 Number of pills actually used
|
2356 Number of pills actually used
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=60 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=60 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=59 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Self-reported Side Effect or Symptom Scores
Neurologic side effect
|
12.4 percent of visits between week 6 to 30
|
6.0 percent of visits between week 6 to 30
|
7.8 percent of visits between week 6 to 30
|
14.2 percent of visits between week 6 to 30
|
14.3 percent of visits between week 6 to 30
|
13.3 percent of visits between week 6 to 30
|
6.1 percent of visits between week 6 to 30
|
3.3 percent of visits between week 6 to 30
|
4.5 percent of visits between week 6 to 30
|
—
|
—
|
—
|
|
Self-reported Side Effect or Symptom Scores
Gastrointestinal side effects
|
10.6 percent of visits between week 6 to 30
|
8.8 percent of visits between week 6 to 30
|
5.4 percent of visits between week 6 to 30
|
13.1 percent of visits between week 6 to 30
|
8.5 percent of visits between week 6 to 30
|
10.5 percent of visits between week 6 to 30
|
8 percent of visits between week 6 to 30
|
5.8 percent of visits between week 6 to 30
|
7.1 percent of visits between week 6 to 30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomizationPopulation: Note: Not all participants were available to be analyzed at each visits below, this could be due to missed visit, drug concentration was missing, or participants did not report to have any sex in the last 7 days
Below we presented the percentages of total cohort with TFV-DP concentrations consistent with \>=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC \>5.2 fmol/10\^6 cells is considered as participants taken \>=2 tablets per week; DBS \>=326 fmol/punch is considered as participants taken \>=2 tablets per week
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=60 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=60 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=59 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
Week 10
|
33 Participants
|
16 Participants
|
25 Participants
|
31 Participants
|
29 Participants
|
30 Participants
|
13 Participants
|
8 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
Week 18
|
29 Participants
|
16 Participants
|
10 Participants
|
28 Participants
|
30 Participants
|
24 Participants
|
11 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
Week 30
|
19 Participants
|
13 Participants
|
12 Participants
|
22 Participants
|
18 Participants
|
13 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=60 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=60 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=59 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Hepatobiliary disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Cardiac disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Eye disorders · Mild
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Gastrointestinal disorders · None
|
33 Participants
|
32 Participants
|
32 Participants
|
30 Participants
|
35 Participants
|
32 Participants
|
30 Participants
|
31 Participants
|
31 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Infections and infestations · Mild
|
11 Participants
|
10 Participants
|
15 Participants
|
22 Participants
|
33 Participants
|
28 Participants
|
22 Participants
|
21 Participants
|
21 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Nervous system disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Reproductive system and breast disorders · Moderate
|
7 Participants
|
8 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Social circumstances · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Injury, poisoning and procedural complications · Severe
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Injury, poisoning and procedural complications · Potentically Life Threatening
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Psychiatric disorders · None
|
55 Participants
|
56 Participants
|
56 Participants
|
52 Participants
|
49 Participants
|
51 Participants
|
46 Participants
|
48 Participants
|
52 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Renal and urinary disorders · Mild
|
10 Participants
|
11 Participants
|
11 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
12 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Ear and labyrinth disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Ear and labyrinth disorders · None
|
58 Participants
|
56 Participants
|
60 Participants
|
59 Participants
|
59 Participants
|
58 Participants
|
58 Participants
|
60 Participants
|
59 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Eye disorders · Moderate
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Eye disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Eye disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Eye disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Eye disorders · None
|
55 Participants
|
57 Participants
|
59 Participants
|
59 Participants
|
59 Participants
|
59 Participants
|
57 Participants
|
60 Participants
|
58 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Gastrointestinal disorders · Mild
|
18 Participants
|
17 Participants
|
18 Participants
|
24 Participants
|
22 Participants
|
23 Participants
|
28 Participants
|
27 Participants
|
28 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Gastrointestinal disorders · Moderate
|
8 Participants
|
9 Participants
|
10 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Gastrointestinal disorders · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Gastrointestinal disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Gastrointestinal disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
General disorders and administration site conditio · Mild
|
9 Participants
|
5 Participants
|
7 Participants
|
10 Participants
|
16 Participants
|
11 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
General disorders and administration site conditio · Moderate
|
0 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
General disorders and administration site conditio · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
General disorders and administration site conditio · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
General disorders and administration site conditio · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
General disorders and administration site conditio · None
|
50 Participants
|
52 Participants
|
48 Participants
|
50 Participants
|
43 Participants
|
47 Participants
|
46 Participants
|
49 Participants
|
52 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Hepatobiliary disorders · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Hepatobiliary disorders · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Hepatobiliary disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Hepatobiliary disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Hepatobiliary disorders · None
|
59 Participants
|
58 Participants
|
60 Participants
|
60 Participants
|
58 Participants
|
59 Participants
|
59 Participants
|
60 Participants
|
60 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Immune system disorders · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Immune system disorders · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Immune system disorders · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Immune system disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Immune system disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Immune system disorders · None
|
59 Participants
|
59 Participants
|
58 Participants
|
60 Participants
|
59 Participants
|
59 Participants
|
59 Participants
|
59 Participants
|
59 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Infections and infestations · Moderate
|
25 Participants
|
25 Participants
|
21 Participants
|
8 Participants
|
6 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Infections and infestations · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Infections and infestations · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Infections and infestations · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Infections and infestations · None
|
23 Participants
|
24 Participants
|
24 Participants
|
27 Participants
|
19 Participants
|
19 Participants
|
37 Participants
|
39 Participants
|
37 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Injury, poisoning and procedural complications · Mild
|
7 Participants
|
5 Participants
|
11 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
17 Participants
|
18 Participants
|
14 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Injury, poisoning and procedural complications · Moderate
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Injury, poisoning and procedural complications · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Injury, poisoning and procedural complications · None
|
48 Participants
|
51 Participants
|
46 Participants
|
44 Participants
|
41 Participants
|
44 Participants
|
38 Participants
|
41 Participants
|
45 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Investigations · Mild
|
13 Participants
|
15 Participants
|
13 Participants
|
18 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Investigations · Moderate
|
5 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Investigations · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Investigations · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Investigations · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Investigations · None
|
41 Participants
|
38 Participants
|
43 Participants
|
35 Participants
|
47 Participants
|
48 Participants
|
50 Participants
|
50 Participants
|
52 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Metabolism and nutrition disorders · Mild
|
0 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Metabolism and nutrition disorders · Moderate
|
6 Participants
|
5 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Metabolism and nutrition disorders · Severe
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Metabolism and nutrition disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Metabolism and nutrition disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Metabolism and nutrition disorders · None
|
50 Participants
|
49 Participants
|
43 Participants
|
60 Participants
|
58 Participants
|
58 Participants
|
52 Participants
|
53 Participants
|
51 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Musculoskeletal and connective tissue disorders · Mild
|
6 Participants
|
6 Participants
|
9 Participants
|
13 Participants
|
15 Participants
|
13 Participants
|
13 Participants
|
11 Participants
|
9 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Musculoskeletal and connective tissue disorders · Moderate
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Musculoskeletal and connective tissue disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Musculoskeletal and connective tissue disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Musculoskeletal and connective tissue disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Musculoskeletal and connective tissue disorders · None
|
50 Participants
|
51 Participants
|
50 Participants
|
43 Participants
|
43 Participants
|
44 Participants
|
46 Participants
|
49 Participants
|
51 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Nervous system disorders · Mild
|
17 Participants
|
14 Participants
|
19 Participants
|
17 Participants
|
18 Participants
|
22 Participants
|
16 Participants
|
10 Participants
|
17 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Nervous system disorders · Moderate
|
15 Participants
|
11 Participants
|
12 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Nervous system disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Nervous system disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Nervous system disorders · None
|
27 Participants
|
34 Participants
|
29 Participants
|
39 Participants
|
41 Participants
|
36 Participants
|
42 Participants
|
47 Participants
|
43 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Pregnancy, puerperium and perinatal conditions · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Pregnancy, puerperium and perinatal conditions · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Pregnancy, puerperium and perinatal conditions · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Pregnancy, puerperium and perinatal conditions · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Pregnancy, puerperium and perinatal conditions · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Pregnancy, puerperium and perinatal conditions · None
|
58 Participants
|
59 Participants
|
60 Participants
|
60 Participants
|
59 Participants
|
59 Participants
|
59 Participants
|
60 Participants
|
60 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Psychiatric disorders · Mild
|
1 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Psychiatric disorders · Moderate
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Psychiatric disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Psychiatric disorders · Potentically Life Threatening
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Psychiatric disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Renal and urinary disorders · Moderate
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Renal and urinary disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Renal and urinary disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Renal and urinary disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Renal and urinary disorders · None
|
45 Participants
|
46 Participants
|
46 Participants
|
59 Participants
|
55 Participants
|
56 Participants
|
47 Participants
|
50 Participants
|
52 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Reproductive system and breast disorders · Mild
|
13 Participants
|
17 Participants
|
17 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Reproductive system and breast disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Reproductive system and breast disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Reproductive system and breast disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Reproductive system and breast disorders · None
|
39 Participants
|
34 Participants
|
34 Participants
|
60 Participants
|
59 Participants
|
57 Participants
|
58 Participants
|
58 Participants
|
57 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Respiratory, thoracic and mediastinal disorders · Mild
|
5 Participants
|
5 Participants
|
9 Participants
|
36 Participants
|
23 Participants
|
29 Participants
|
18 Participants
|
19 Participants
|
18 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Respiratory, thoracic and mediastinal disorders · Moderate
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Respiratory, thoracic and mediastinal disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Respiratory, thoracic and mediastinal disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Respiratory, thoracic and mediastinal disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Respiratory, thoracic and mediastinal disorders · None
|
49 Participants
|
52 Participants
|
50 Participants
|
24 Participants
|
36 Participants
|
29 Participants
|
41 Participants
|
41 Participants
|
42 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Skin and subcutaneous tissue disorders · Mild
|
6 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
15 Participants
|
10 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Skin and subcutaneous tissue disorders · Moderate
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Skin and subcutaneous tissue disorders · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Skin and subcutaneous tissue disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Skin and subcutaneous tissue disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Skin and subcutaneous tissue disorders · None
|
49 Participants
|
48 Participants
|
48 Participants
|
50 Participants
|
44 Participants
|
46 Participants
|
51 Participants
|
55 Participants
|
55 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Social circumstances · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Social circumstances · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Social circumstances · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Social circumstances · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Social circumstances · None
|
58 Participants
|
59 Participants
|
60 Participants
|
60 Participants
|
59 Participants
|
59 Participants
|
59 Participants
|
60 Participants
|
60 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Vascular disorders · Mild
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Vascular disorders · Moderate
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Vascular disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Vascular disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Vascular disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Vascular disorders · None
|
56 Participants
|
55 Participants
|
59 Participants
|
60 Participants
|
59 Participants
|
58 Participants
|
57 Participants
|
60 Participants
|
60 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Neoplasms benign, malignant, and unspecified · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Neoplasms benign, malignant, and unspecified · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Neoplasms benign, malignant, and unspecified · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Neoplasms benign, malignant, and unspecified · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Neoplasms benign, malignant, and unspecified · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Neoplasms benign, malignant, and unspecified · None
|
59 Participants
|
59 Participants
|
60 Participants
|
60 Participants
|
59 Participants
|
58 Participants
|
59 Participants
|
60 Participants
|
60 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Blood and lymphatic system disorders : Mild · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Blood and lymphatic system disorders : Mild · Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Blood and lymphatic system disorders : Mild · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Blood and lymphatic system disorders : Mild · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Blood and lymphatic system disorders : Mild · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Blood and lymphatic system disorders : Mild · None
|
57 Participants
|
57 Participants
|
59 Participants
|
60 Participants
|
59 Participants
|
59 Participants
|
57 Participants
|
58 Participants
|
58 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Cardiac disorders · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Cardiac disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Cardiac disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Cardiac disorders · Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Cardiac disorders · None
|
59 Participants
|
59 Participants
|
59 Participants
|
58 Participants
|
58 Participants
|
58 Participants
|
58 Participants
|
60 Participants
|
60 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Ear and labyrinth disorders · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Ear and labyrinth disorders · Moderate
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Ear and labyrinth disorders · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Ear and labyrinth disorders · Potentically Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment to week 30 (end of self-administered dosing)Population: Data is collected for plasma HIV RNA levels among all participants who seroconvert while on study, but this secondary analysis has not been carried out yet, so no outcome measure is presented here
Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study.
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=191 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=193 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=238 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Before Randomization · Drug Resistance
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Before Randomization · No Drug Resistance
|
190 Participants
|
193 Participants
|
237 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
After Randomization (Daily dosing) · Drug Resistance
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
After Randomization (Daily dosing) · No Drug Resistance
|
59 Participants
|
60 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
After Randomization (Time-driven dosing) · Drug Resistance
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
After Randomization (Time-driven dosing) · No Drug Resistance
|
58 Participants
|
59 Participants
|
60 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
After Randomization (Event-driven dosing) · Drug Resistance
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
After Randomization (Event-driven dosing) · No Drug Resistance
|
60 Participants
|
59 Participants
|
60 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=60 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=60 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=59 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data
|
75 % of Correctly Timed Adherence
|
65 % of Correctly Timed Adherence
|
53 % of Correctly Timed Adherence
|
85 % of Correctly Timed Adherence
|
79 % of Correctly Timed Adherence
|
65 % of Correctly Timed Adherence
|
65 % of Correctly Timed Adherence
|
47 % of Correctly Timed Adherence
|
41 % of Correctly Timed Adherence
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 6 to Week 30Population: Number of participants had product hold or product discontinuation log
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=7 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=7 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=8 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=12 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=3 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=5 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=2 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=7 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=2 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews
Pregnancy
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews
Other
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews
HIV-positive result
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews
Other adverse experience
|
6 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)Population: Below "Number analyzed" population only included the participants who had below adverse events, and the number next to it represent the number of participants had the corresponding AE that was related to the study product
Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm.
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=59 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=60 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=60 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=59 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=59 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=60 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Infections and infestations
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Cardiac disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Ear and labyrinth disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Eye disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Investigations
|
10 Participants
|
13 Participants
|
12 Participants
|
23 Participants
|
12 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Metabolism and nutrition disorders
|
2 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Injury, poisoning and procedural complications
|
3 Participants
|
4 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
10 Participants
|
13 Participants
|
16 Participants
|
10 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Musculoskeletal and connective tissue disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Neoplasms benign, malignant, and unspecified
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Nervous system disorders
|
17 Participants
|
17 Participants
|
21 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Respiratory, thoracic and mediastinal disorders
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Skin and subcutaneous tissue disorders
|
4 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Social circumstances
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Vascular disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Blood and lymphatic system disorders
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Gastrointestinal disorders
|
18 Participants
|
17 Participants
|
24 Participants
|
9 Participants
|
1 Participants
|
2 Participants
|
13 Participants
|
13 Participants
|
16 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
General disorders and administration site conditio
|
4 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Hepatobiliary disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Immune system disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Pregnancy, puerperium and perinatal conditions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Psychiatric disorders
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Renal and urinary disorders
|
10 Participants
|
5 Participants
|
10 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
|
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Reproductive system and breast disorders
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Enrollment to week 30 (end of self-administered dosing)Population: Below, each seroconverted participants' plasma HIV RNA levels at all visits with test results are presented
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm.
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=1 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=1 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=1 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=1 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=1 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=1 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=1 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=1 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=1 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
n=1 Participants
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
n=1 Participants
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
n=1 Participants
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Enrollment
|
20 viral load
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Day 3
|
400 viral load
|
400 viral load
|
—
|
—
|
—
|
—
|
—
|
—
|
40 viral load
|
78450 viral load
|
400 viral load
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 4
|
3460 viral load
|
3667690 viral load
|
—
|
—
|
—
|
—
|
—
|
—
|
749590 viral load
|
710 viral load
|
40900 viral load
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 5
|
5732050 viral load
|
3938670 viral load
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1570 viral load
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 6
|
—
|
—
|
—
|
400 viral load
|
—
|
—
|
—
|
—
|
92960 viral load
|
5070 viral load
|
83260 viral load
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 10
|
416070 viral load
|
93040 viral load
|
—
|
400 viral load
|
—
|
—
|
—
|
—
|
1799950 viral load
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 14
|
—
|
93660 viral load
|
—
|
400 viral load
|
—
|
2100 viral load
|
—
|
—
|
119720 viral load
|
—
|
—
|
1567040 viral load
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 18
|
—
|
114520 viral load
|
—
|
650 viral load
|
—
|
3710 viral load
|
83010 viral load
|
—
|
127330 viral load
|
—
|
—
|
73030 viral load
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 22
|
—
|
178210 viral load
|
—
|
400 viral load
|
5887760 viral load
|
127480 viral load
|
136310 viral load
|
—
|
178070 viral load
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 26
|
—
|
89970 viral load
|
503950 viral load
|
—
|
—
|
220830 viral load
|
25020 viral load
|
400 viral load
|
96180 viral load
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 30
|
—
|
35210 viral load
|
10910 viral load
|
—
|
—
|
193130 viral load
|
29390 viral load
|
400 viral load
|
36140 viral load
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Enrollment to week 30 (end of self-administered dosing)Population: Below, each seroconverted participants' drug resistance test availability was presented. If the number analyzed equal to 0 then it means the resistance test was not done. When the number analyzed equal to 1 and outcome value is 0 then it means no drug resistance was detected, but if the outcome value is 1 then it means drug resistance was detected.
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels
Outcome measures
| Measure |
Daily Dosing, Cape Town
n=1 Participants
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=1 Participants
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=1 Participants
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=1 Participants
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=1 Participants
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=1 Participants
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=1 Participants
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=1 Participants
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=1 Participants
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Bangkok, Thailand, Seroconverted Participant #2
n=1 Participants
#2 seroconverted participants in Bangkok, Thailand, not randomized
|
Harlem, United States, Seroconverted Participant #1
n=1 Participants
#1 seroconverted participants in Harlem, United States, not randomized
|
Harlem, United States, Seroconverted Participant #2
n=1 Participants
#2 seroconverted participants in Harlem, United States, daily arm
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Enrollment
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 4
|
1 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
1 viral load
|
0 viral load
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 5
|
—
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
—
|
0 viral load
|
—
|
0 viral load
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 6
|
—
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
—
|
—
|
0 viral load
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 10
|
—
|
—
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
—
|
—
|
—
|
0 viral load
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 14
|
—
|
—
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
0 viral load
|
—
|
—
|
—
|
0 viral load
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 18
|
—
|
—
|
0 viral load
|
0 viral load
|
0 viral load
|
1 viral load
|
0 viral load
|
0 viral load
|
—
|
—
|
—
|
0 viral load
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 22
|
—
|
—
|
0 viral load
|
0 viral load
|
0 viral load
|
—
|
0 viral load
|
0 viral load
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 26
|
—
|
—
|
0 viral load
|
—
|
—
|
—
|
—
|
0 viral load
|
—
|
—
|
—
|
—
|
|
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Week 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 viral load
|
—
|
—
|
—
|
—
|
Adverse Events
Daily Dosing, Cape Town
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
Time-driven Dosing, Cape Town
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Event-driven Dosing, Cape Town
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Daily Dosing, Bangkok
Serious events: 5 serious events
Other events: 58 other events
Deaths: 0 deaths
Time-driven Dosing, Bangkok
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
Event-driven Dosing, Bangkok
Serious events: 3 serious events
Other events: 58 other events
Deaths: 0 deaths
Daily Dosing, Harlem
Serious events: 3 serious events
Other events: 53 other events
Deaths: 0 deaths
Time-driven Dosing, Harlem
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
Event-driven Dosing, Harlem
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daily Dosing, Cape Town
n=59 participants at risk
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=59 participants at risk
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=60 participants at risk
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=60 participants at risk
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=59 participants at risk
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=59 participants at risk
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=59 participants at risk
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=60 participants at risk
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=60 participants at risk
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Headache
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Dengue fever
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Influenza
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Major depression
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Syncope
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
Other adverse events
| Measure |
Daily Dosing, Cape Town
n=59 participants at risk
Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Cape Town
n=59 participants at risk
Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Cape Town
n=60 participants at risk
Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Bangkok
n=60 participants at risk
Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Bangkok
n=59 participants at risk
Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Bangkok
n=59 participants at risk
Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Daily Dosing, Harlem
n=59 participants at risk
Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Time-driven Dosing, Harlem
n=60 participants at risk
Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
Event-driven Dosing, Harlem
n=60 participants at risk
Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.7%
7/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Abscess oral
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
8/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.7%
7/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
15.0%
9/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Alcoholic hangover
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Anal abscess
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Anal fissure
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Asthenia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
16.7%
10/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Blood phosphorus decreased
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Blood pressure increased
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.6%
8/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Blood sodium decreased
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Body tinea
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Breast pain
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Breast tenderness
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Chest discomfort
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Chest pain
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Chills
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Coital bleeding
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Eye disorders
Conjunctival haemorrhage
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.3%
8/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
15.0%
9/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
15.3%
9/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Cyst
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Cystitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Dengue fever
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Depression
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
15.0%
9/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
21.7%
13/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.6%
8/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
20.3%
12/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
22.0%
13/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
20.0%
12/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Dizziness
|
15.3%
9/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
18.3%
11/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.3%
8/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Renal and urinary disorders
Dysuria
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Ear infection fungal
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Ear and labyrinth disorders
Ear pain
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Ejaculation failure
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Eye disorders
Episcleritis
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Eye infection
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Eye disorders
Eye pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Eye disorders
Eye pruritus
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Eyelid infection
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Fatigue
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.3%
8/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.7%
7/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Feeling hot
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.3%
8/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.7%
7/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Vascular disorders
Flushing
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Folliculitis
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
15.3%
9/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Fungal skin infection
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Furuncle
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Galactorrhoea
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Gastritis
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Gastroenteritis
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Gastroenteritis viral
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Genital herpes
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Genital ulceration
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Gingival injury
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Glucose urine
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Renal and urinary disorders
Glycosuria
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Haemoglobin decreased
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Hangover
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Headache
|
40.7%
24/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
33.9%
20/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
36.7%
22/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
21.7%
13/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
20.3%
12/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
28.8%
17/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
15.3%
9/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.3%
8/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
23.3%
14/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Heart rate increased
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Hordeolum
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Vascular disorders
Hot flush
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Vascular disorders
Hypertension
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Vascular disorders
Hypotension
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Influenza
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Influenza like illness
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Lice infestation
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Loss of libido
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Major depression
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Malaise
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
25.4%
15/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
32.2%
19/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
36.7%
22/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Migraine
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.6%
8/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.3%
8/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.7%
7/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
43.3%
26/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
57.6%
34/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
45.8%
27/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
16.7%
10/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Nausea
|
18.6%
11/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
20.3%
12/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
25.0%
15/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
15.0%
9/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.3%
8/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Neutrophil count decreased
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Nipple pain
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Oedema peripheral
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
45.0%
27/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
25.4%
15/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
37.3%
22/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Otitis media
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Overdose
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Papule
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Penis disorder
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Peripheral swelling
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Pharyngitis
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Vascular disorders
Phlebitis
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Post procedural diarrhoea
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Procedural headache
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.6%
8/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.7%
7/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
Protein urine present
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Renal and urinary disorders
Proteinuria
|
20.3%
12/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
16.9%
10/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
18.3%
11/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
16.9%
10/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.3%
8/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Eye disorders
Pterygium
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
General disorders
Pyrexia
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Respiratory tract infection
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.0%
6/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
21.7%
13/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Sexually transmitted disease
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.6%
8/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.3%
5/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Shigella infection
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Sinusitis
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Skin infection
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Stab wound
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Stress
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Subcutaneous abscess
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Psychiatric disorders
Suicide attempt
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Syncope
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Syphilis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Nervous system disorders
Tension headache
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Tinea faciei
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Tonsillitis
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Toothache
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Trench foot
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
6/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
8.5%
5/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
16.7%
10/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Urethritis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Urethritis chlamydial
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Urethritis gonococcal
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Renal and urinary disorders
Urethritis noninfective
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Urinary tract infection
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
13.6%
8/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.1%
3/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Social circumstances
Victim of sexual abuse
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Viral infection
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.3%
2/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.3%
12/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
22.0%
13/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
26.7%
16/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Eye disorders
Vision blurred
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Gastrointestinal disorders
Vomiting
|
16.9%
10/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
5.0%
3/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
11.9%
7/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.7%
4/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
3.4%
2/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
6.8%
4/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
1.7%
1/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/59 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
0.00%
0/60 • From week 6 (randomization week) to week 30 (end of self-administered dosing)
|
Additional Information
Maoji Li (Statistical Research Associate)
Fred Hutchinson Cancer Research Center
Phone: 2066676035
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All study abstracts and publications are subject to HPTN Publication and Public Information Policies and Clinical Trial Agreements between NIAID (DAIDS) and company collaborators. The publication or other disclosure can be delayed for up to thirty additional business days for manuscripts and five business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER