Trial Outcomes & Findings for Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults (NCT NCT02178800)
NCT ID: NCT02178800
Last Updated: 2021-10-18
Results Overview
An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
199 participants
Primary outcome timeframe
Measured through Week 41
Results posted on
2021-10-18
Participant Flow
Participant milestones
| Measure |
Group 1: GSK1265744
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
48
|
|
Overall Study
COMPLETED
|
131
|
42
|
|
Overall Study
NOT COMPLETED
|
20
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults
Baseline characteristics by cohort
| Measure |
Group 1: GSK1265744
n=151 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=48 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
35 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
33 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Age, Customized
18 - 25
|
52 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Customized
26 - 35
|
53 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Customized
36 - 45
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Customized
46 - 55
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Customized
56 - 65
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
36 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic Black
|
64 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic White
|
42 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic mixed/other
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Region of Enrollment
Malawi
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
24 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
33 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured through Week 41Population: This population includes participants who receive at least one injection in the study.
An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Outcome measures
| Measure |
Group 1: GSK1265744
n=134 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=43 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)
|
121 Participants
|
38 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through Week 41Population: This population includes participants who received at least one injection in the study.
Stratified by arm
Outcome measures
| Measure |
Group 1: GSK1265744
n=134 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=43 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinue Injectable Study Product for Reasons of Toxicity, Tolerability, or Acceptability That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)
|
11 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through Week 41Population: PK sample size varies by visit due to reasons such as missing visits, different schedule and sample contamination.
Geometric means and 90% prediction intervals by sex at birth and cohort are reported.
Outcome measures
| Measure |
Group 1: GSK1265744
n=49 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=25 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
n=40 Participants
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
n=20 Participants
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 13
|
1.18 ug/ml
Interval 0.52 to 2.69
|
0.90 ug/ml
Interval 0.4 to 2.01
|
2.24 ug/ml
Interval 0.89 to 5.65
|
2.55 ug/ml
Interval 1.22 to 5.33
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 17
|
0.95 ug/ml
Interval 0.42 to 2.14
|
0.49 ug/ml
Interval 0.19 to 1.31
|
1.82 ug/ml
Interval 0.79 to 4.21
|
1.29 ug/ml
Interval 0.54 to 3.09
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 18
|
2.11 ug/ml
Interval 0.94 to 4.75
|
2.33 ug/ml
Interval 0.72 to 7.53
|
3.09 ug/ml
Interval 1.32 to 7.25
|
2.73 ug/ml
Interval 1.03 to 7.29
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 25
|
—
|
—
|
2.00 ug/ml
Interval 0.96 to 4.16
|
1.11 ug/ml
Interval 0.38 to 3.2
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 26
|
—
|
—
|
3.07 ug/ml
Interval 1.3 to 7.27
|
2.84 ug/ml
Interval 1.24 to 6.49
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 34
|
—
|
—
|
3.59 ug/ml
Interval 1.5 to 8.58
|
3.60 ug/ml
Interval 1.48 to 8.74
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 6
|
1.32 ug/ml
Interval 0.49 to 3.54
|
2.40 ug/ml
Interval 0.63 to 9.22
|
1.29 ug/ml
Interval 0.33 to 5.05
|
2.28 ug/ml
Interval 0.67 to 7.72
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 9
|
1.49 ug/ml
Interval 0.53 to 4.18
|
1.77 ug/ml
Interval 0.7 to 4.47
|
1.31 ug/ml
Interval 0.38 to 4.44
|
1.79 ug/ml
Interval 0.93 to 3.44
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 10
|
—
|
—
|
2.56 ug/ml
Interval 0.94 to 6.98
|
3.58 ug/ml
Interval 1.42 to 9.0
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 21
|
—
|
—
|
2.74 ug/ml
Interval 1.29 to 5.79
|
2.07 ug/ml
Interval 0.87 to 4.9
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 23
|
2.02 ug/ml
Interval 0.86 to 4.74
|
1.48 ug/ml
Interval 0.84 to 2.59
|
—
|
—
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 29
|
1.37 ug/ml
Interval 0.61 to 3.06
|
0.78 ug/ml
Interval 0.3 to 2.02
|
2.68 ug/ml
Interval 1.23 to 5.81
|
2.17 ug/ml
Interval 0.98 to 4.81
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 30
|
2.78 ug/ml
Interval 1.23 to 6.28
|
3.48 ug/ml
Interval 1.43 to 8.48
|
—
|
—
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 33
|
—
|
—
|
2.10 ug/ml
Interval 0.94 to 4.7
|
1.50 ug/ml
Interval 0.55 to 4.11
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 35
|
2.41 ug/ml
Interval 1.03 to 5.61
|
1.85 ug/ml
Interval 1.07 to 3.2
|
—
|
—
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 37
|
—
|
—
|
2.73 ug/ml
Interval 1.06 to 7.06
|
2.71 ug/ml
Interval 1.67 to 4.4
|
|
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Week 41
|
1.68 ug/ml
Interval 0.78 to 3.62
|
0.82 ug/ml
Interval 0.27 to 2.54
|
2.06 ug/ml
Interval 0.77 to 5.49
|
1.68 ug/ml
Interval 0.68 to 4.17
|
SECONDARY outcome
Timeframe: Measured from 12 weeks after last injection through Week 105 for Cohort 1 and 8 weeks after last injection through Week 109 for Cohort 2Population: This includes participants who entered tail phase
An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Outcome measures
| Measure |
Group 1: GSK1265744
n=130 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=42 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities During Tail Phase
|
107 Participants
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 5An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Outcome measures
| Measure |
Group 1: GSK1265744
n=151 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=48 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Prior to Completion of the Oral Phase
|
84 Participants
|
25 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured from week 6 through Week 30 in cohort 1 and Week 34 in cohort 2Population: Sample size varies by visit due to reasons such as missing visits and different schedules.
Stratified by Visit and Cohort
Outcome measures
| Measure |
Group 1: GSK1265744
n=98 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=78 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future
Week 6
|
80 Participants
|
74 Participants
|
—
|
—
|
|
Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future
Week 10
|
—
|
74 Participants
|
—
|
—
|
|
Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future
Week 18
|
81 Participants
|
73 Participants
|
—
|
—
|
|
Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future
Week 26
|
—
|
71 Participants
|
—
|
—
|
|
Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future
Week 30
|
69 Participants
|
—
|
—
|
—
|
|
Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future
Week 34
|
—
|
65 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 105 for Cohort 1 and Week 109 for Cohort 2Outcome measures
| Measure |
Group 1: GSK1265744
n=151 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=48 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Participants With HIV Infections Through the Study Period, Stratified by Arm
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 77Population: Analysis sample size is different at each visit due to multiple reasons (early termination, missing data, study unblinding, etc.)
Week 29/31 is a combination of week 29, cohort 1 and week 33, cohort 2. The outcome in this table is stratified by arm.
Outcome measures
| Measure |
Group 1: GSK1265744
n=151 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=48 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Week 5
|
0.84 partners
Standard Deviation 0.44
|
0.78 partners
Standard Deviation 0.67
|
—
|
—
|
|
Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Week 17
|
0.81 partners
Standard Deviation 0.54
|
0.84 partners
Standard Deviation 0.57
|
—
|
—
|
|
Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Week 77
|
0.84 partners
Standard Deviation 0.61
|
0.82 partners
Standard Deviation 0.50
|
—
|
—
|
|
Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Enrollment Visit
|
0.81 partners
Standard Deviation 0.46
|
0.92 partners
Standard Deviation 0.65
|
—
|
—
|
|
Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Week 29/33
|
0.85 partners
Standard Deviation 0.57
|
0.80 partners
Standard Deviation 0.46
|
—
|
—
|
|
Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Week 41
|
0.85 partners
Standard Deviation 0.66
|
0.88 partners
Standard Deviation 0.45
|
—
|
—
|
|
Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Week 53
|
0.84 partners
Standard Deviation 0.62
|
0.83 partners
Standard Deviation 0.50
|
—
|
—
|
|
Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Week 65
|
0.87 partners
Standard Deviation 0.76
|
0.88 partners
Standard Deviation 0.48
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 4Population: This population includes injectable hormonal-contraception-using female participants in the study
An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Outcome measures
| Measure |
Group 1: GSK1265744
n=34 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=13 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Oral Phase
|
17 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured from first injection through 12 weeks after last injection for Cohort 1 and 8 weeks after last injection for Cohort 2Population: This population includes injectable hormonal-contraception-using female participants who received at least one injection of study drug in the study
Outcome measures
| Measure |
Group 1: GSK1265744
n=32 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=12 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Injection Phase
|
29 Participants
|
12 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 4Population: This population includes injectable hormonal-contraception-using female participants in the study
Stratified by arm
Outcome measures
| Measure |
Group 1: GSK1265744
n=34 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=13 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Oral Phase
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured from first injection through 12 weeks after last injection for Cohort 1 and 8 weeks after last injection for Cohort 2Population: This population includes injectable hormonal-contraception-using female participants who received at least one injection of study drug in the study
Outcome measures
| Measure |
Group 1: GSK1265744
n=32 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=12 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Injection Phase
|
3 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 4Stratified by arm
Outcome measures
| Measure |
Group 1: GSK1265744
n=151 Participants
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=48 Participants
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
Female, Cohort 2
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
Male, Cohort 2
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinue Oral Study Product for Reasons of Toxicity, Tolerability, or Acceptability Prior to Completion of the Oral Phase
|
6 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Group 1: GSK1265744
Serious events: 4 serious events
Other events: 147 other events
Deaths: 0 deaths
Group 2: Placebo
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: GSK1265744
n=151 participants at risk
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=48 participants at risk
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Sensory loss
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Laryngitis bacterial
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
Other adverse events
| Measure |
Group 1: GSK1265744
n=151 participants at risk
Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
GSK1265744 Tablets: 30-mg tablets, taken orally
Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection
|
Group 2: Placebo
n=48 participants at risk
Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.
Placebo for GSK1265744 Tablets: Taken orally
Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
2/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
4.6%
7/151 • Number of events 9 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
3/151 • Number of events 4 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Psychiatric disorders
Abnormal dreams
|
5.3%
8/151 • Number of events 12 • 41 weeks
|
8.3%
4/48 • Number of events 4 • 41 weeks
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
2.6%
4/151 • Number of events 5 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Acute sinusitis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Alanine aminotransferase increased
|
11.9%
18/151 • Number of events 26 • 41 weeks
|
10.4%
5/48 • Number of events 8 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic pharyngitis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Amylase decreased
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Amylase increased
|
11.9%
18/151 • Number of events 32 • 41 weeks
|
10.4%
5/48 • Number of events 10 • 41 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Psychiatric disorders
Anxiety
|
2.6%
4/151 • Number of events 4 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
11/151 • Number of events 13 • 41 weeks
|
6.2%
3/48 • Number of events 3 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
13/151 • Number of events 18 • 41 weeks
|
6.2%
3/48 • Number of events 4 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
16/151 • Number of events 18 • 41 weeks
|
6.2%
3/48 • Number of events 3 • 41 weeks
|
|
Infections and infestations
Bacterial vaginosis
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Bilirubin conjugated increased
|
4.6%
7/151 • Number of events 10 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Investigations
Blood bicarbonate decreased
|
15.9%
24/151 • Number of events 43 • 41 weeks
|
20.8%
10/48 • Number of events 18 • 41 weeks
|
|
Investigations
Blood bilirubin increased
|
2.0%
3/151 • Number of events 5 • 41 weeks
|
6.2%
3/48 • Number of events 5 • 41 weeks
|
|
Investigations
Blood calcium decreased
|
6.0%
9/151 • Number of events 10 • 41 weeks
|
8.3%
4/48 • Number of events 8 • 41 weeks
|
|
Investigations
Blood calcium increased
|
3.3%
5/151 • Number of events 5 • 41 weeks
|
6.2%
3/48 • Number of events 3 • 41 weeks
|
|
Investigations
Blood cholesterol increased
|
3.3%
5/151 • Number of events 5 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
16.6%
25/151 • Number of events 37 • 41 weeks
|
16.7%
8/48 • Number of events 14 • 41 weeks
|
|
Investigations
Blood creatinine increased
|
12.6%
19/151 • Number of events 33 • 41 weeks
|
8.3%
4/48 • Number of events 6 • 41 weeks
|
|
Investigations
Blood glucose decreased
|
19.2%
29/151 • Number of events 56 • 41 weeks
|
22.9%
11/48 • Number of events 19 • 41 weeks
|
|
Investigations
Blood glucose increased
|
37.1%
56/151 • Number of events 99 • 41 weeks
|
43.8%
21/48 • Number of events 39 • 41 weeks
|
|
Investigations
Blood magnesium decreased
|
11.9%
18/151 • Number of events 31 • 41 weeks
|
16.7%
8/48 • Number of events 11 • 41 weeks
|
|
Investigations
Blood magnesium increased
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Blood phosphorus decreased
|
16.6%
25/151 • Number of events 38 • 41 weeks
|
20.8%
10/48 • Number of events 17 • 41 weeks
|
|
Investigations
Blood potassium decreased
|
5.3%
8/151 • Number of events 11 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Investigations
Blood potassium increased
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Investigations
Blood pressure increased
|
4.6%
7/151 • Number of events 9 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Investigations
Blood sodium decreased
|
5.3%
8/151 • Number of events 9 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Investigations
Blood sodium increased
|
5.3%
8/151 • Number of events 11 • 41 weeks
|
6.2%
3/48 • Number of events 3 • 41 weeks
|
|
Investigations
Blood triglycerides increased
|
4.6%
7/151 • Number of events 7 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Body tinea
|
4.0%
6/151 • Number of events 6 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Cardiac disorders
Bradycardia
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Breast cellulitis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Breast mass
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Bronchitis
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Campylobacter infection
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Carbon dioxide decreased
|
5.3%
8/151 • Number of events 15 • 41 weeks
|
6.2%
3/48 • Number of events 5 • 41 weeks
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Cellulitis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Cervicitis
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Chest pain
|
3.3%
5/151 • Number of events 5 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Chikungunya virus infection
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
General disorders
Chills
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Chlamydial infection
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Complication associated with device
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Complication of device insertion
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Complication of device removal
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Conjunctivitis
|
4.6%
7/151 • Number of events 8 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Conjunctivitis bacterial
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Conjunctivitis viral
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.3%
5/151 • Number of events 6 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
4.0%
6/151 • Number of events 7 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
6/151 • Number of events 6 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Creatinine renal clearance decreased
|
47.0%
71/151 • Number of events 168 • 41 weeks
|
43.8%
21/48 • Number of events 47 • 41 weeks
|
|
Infections and infestations
Cutaneous sporotrichosis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Psychiatric disorders
Depressed mood
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/151 • 41 weeks
|
6.2%
3/48 • Number of events 3 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.6%
4/151 • Number of events 5 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Product Issues
Device breakage
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
13/151 • Number of events 16 • 41 weeks
|
12.5%
6/48 • Number of events 10 • 41 weeks
|
|
Nervous system disorders
Disturbance in attention
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Nervous system disorders
Dizziness
|
14.6%
22/151 • Number of events 28 • 41 weeks
|
10.4%
5/48 • Number of events 6 • 41 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
4/151 • Number of events 4 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
2.6%
4/151 • Number of events 4 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
6.2%
3/48 • Number of events 4 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Electrocardiogram PR prolongation
|
2.0%
3/151 • Number of events 4 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
4.6%
7/151 • Number of events 13 • 41 weeks
|
6.2%
3/48 • Number of events 4 • 41 weeks
|
|
Investigations
Electrocardiogram T wave inversion
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
4.2%
2/48 • Number of events 3 • 41 weeks
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Vascular disorders
Essential hypertension
|
0.66%
1/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Eye disorders
Eye irritation
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Eye disorders
Eye pruritus
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Facial paralysis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Faeces soft
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Fatigue
|
7.3%
11/151 • Number of events 15 • 41 weeks
|
12.5%
6/48 • Number of events 7 • 41 weeks
|
|
General disorders
Feeling hot
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Feeling jittery
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Flatulence
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Gastrointestinal disorders
Food poisoning
|
2.6%
4/151 • Number of events 4 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Fungal infection
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Fungal skin infection
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Furuncle
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
5/151 • Number of events 5 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.6%
4/151 • Number of events 5 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
4.0%
6/151 • Number of events 6 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Genital candidiasis
|
1.3%
2/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Genital herpes
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Genital infection fungal
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Gingivitis
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Groin abscess
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Haemoglobin decreased
|
4.0%
6/151 • Number of events 11 • 41 weeks
|
2.1%
1/48 • Number of events 3 • 41 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Headache
|
35.1%
53/151 • Number of events 78 • 41 weeks
|
22.9%
11/48 • Number of events 13 • 41 weeks
|
|
Investigations
Heart rate increased
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Hordeolum
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Human bite
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Hunger
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
4/151 • Number of events 4 • 41 weeks
|
6.2%
3/48 • Number of events 3 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Immune system disorders
Hypersensitivity
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Nervous system disorders
Hypersomnia
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Vascular disorders
Hypertension
|
5.3%
8/151 • Number of events 8 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
4.6%
7/151 • Number of events 10 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Injury, poisoning and procedural complications
Hypobarism
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.6%
7/151 • Number of events 12 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
2/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 3 • 41 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/151 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.0%
6/151 • Number of events 8 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
General disorders
Implant site pain
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
General disorders
Induration
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Infected bite
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Infection parasitic
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Inflammation
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Influenza
|
6.6%
10/151 • Number of events 11 • 41 weeks
|
8.3%
4/48 • Number of events 5 • 41 weeks
|
|
General disorders
Influenza like illness
|
9.9%
15/151 • Number of events 19 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Injection site bruising
|
12.6%
19/151 • Number of events 23 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
General disorders
Injection site dermatitis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Injection site discomfort
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Injection site erythema
|
6.6%
10/151 • Number of events 16 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Injection site induration
|
15.9%
24/151 • Number of events 39 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
General disorders
Injection site nodule
|
4.6%
7/151 • Number of events 9 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Injection site pain
|
79.5%
120/151 • Number of events 567 • 41 weeks
|
22.9%
11/48 • Number of events 29 • 41 weeks
|
|
General disorders
Injection site pruritus
|
2.6%
4/151 • Number of events 6 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Injection site reaction
|
2.6%
4/151 • Number of events 5 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Injection site swelling
|
7.3%
11/151 • Number of events 17 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Injection site warmth
|
2.0%
3/151 • Number of events 4 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Psychiatric disorders
Insomnia
|
8.6%
13/151 • Number of events 18 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Intracranial pressure increased
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.0%
3/151 • Number of events 4 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Psychiatric disorders
Irritability
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.66%
1/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Laryngitis bacterial
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Psychiatric disorders
Libido decreased
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Ligament laxity
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Lipase increased
|
15.2%
23/151 • Number of events 34 • 41 weeks
|
29.2%
14/48 • Number of events 26 • 41 weeks
|
|
Investigations
Low density lipoprotein increased
|
6.0%
9/151 • Number of events 9 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Malaise
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Malaria
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Mastoiditis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.3%
2/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Migraine
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Molluscum contagiosum
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Psychiatric disorders
Mood altered
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Psychiatric disorders
Mood swings
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Ear and labyrinth disorders
Motion sickness
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.6%
13/151 • Number of events 14 • 41 weeks
|
8.3%
4/48 • Number of events 5 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.6%
16/151 • Number of events 19 • 41 weeks
|
8.3%
4/48 • Number of events 7 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
8/151 • Number of events 8 • 41 weeks
|
8.3%
4/48 • Number of events 4 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
8/151 • Number of events 8 • 41 weeks
|
8.3%
4/48 • Number of events 7 • 41 weeks
|
|
Gastrointestinal disorders
Nausea
|
11.9%
18/151 • Number of events 23 • 41 weeks
|
10.4%
5/48 • Number of events 7 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
8/151 • Number of events 8 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Nerve compression
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Neutrophil count decreased
|
1.3%
2/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
Eye disorders
Night blindness
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Oedema peripheral
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Oral herpes
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
5/151 • Number of events 5 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Otitis externa
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Pain
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
10/151 • Number of events 10 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Nervous system disorders
Paraesthesia
|
4.6%
7/151 • Number of events 9 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/151 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Pelvic inflammatory disease
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Periorbital cellulitis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal exudate
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Pharyngitis
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Pharyngitis bacterial
|
2.0%
3/151 • Number of events 4 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Eye disorders
Photophobia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Platelet count decreased
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Renal and urinary disorders
Polyuria
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Post procedural infection
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Presyncope
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.6%
4/151 • Number of events 4 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Proctitis chlamydial
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Investigations
Protein urine
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Renal and urinary disorders
Proteinuria
|
3.3%
5/151 • Number of events 5 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
4/151 • Number of events 4 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.0%
3/151 • Number of events 4 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Eye disorders
Pseudopapilloedema
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Puncture site pain
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Pyrexia
|
6.0%
9/151 • Number of events 10 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
4/151 • Number of events 4 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Rhinitis
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.6%
4/151 • Number of events 5 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Schistosomiasis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Seizure
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Cardiac disorders
Sinus arrhythmia
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Sinusitis
|
3.3%
5/151 • Number of events 6 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Sinusitis bacterial
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.3%
2/151 • Number of events 4 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Somnolence
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Nervous system disorders
Spinal cord compression
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Psychiatric disorders
Stress
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Tension headache
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
General disorders
Thirst
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Tinea cruris
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Tinea infection
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Tinea versicolour
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Tongue coated
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Tonsillitis
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Tonsillitis bacterial
|
2.6%
4/151 • Number of events 4 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Tooth abscess
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Tooth impacted
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Toothache
|
2.0%
3/151 • Number of events 3 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Nervous system disorders
Tremor
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Trichoglossia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
16.6%
25/151 • Number of events 41 • 41 weeks
|
22.9%
11/48 • Number of events 13 • 41 weeks
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
6.6%
10/151 • Number of events 13 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Urethritis gonococcal
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.0%
9/151 • Number of events 11 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Infections and infestations
Urinary tract infection bacterial
|
4.6%
7/151 • Number of events 9 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.6%
4/151 • Number of events 8 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.3%
5/151 • Number of events 5 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Vessel puncture site haematoma
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Viral infection
|
3.3%
5/151 • Number of events 5 • 41 weeks
|
4.2%
2/48 • Number of events 3 • 41 weeks
|
|
Infections and infestations
Viral pharyngitis
|
3.3%
5/151 • Number of events 5 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Viral rhinitis
|
4.0%
6/151 • Number of events 9 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Viral tonsillitis
|
0.66%
1/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.6%
16/151 • Number of events 18 • 41 weeks
|
16.7%
8/48 • Number of events 10 • 41 weeks
|
|
Eye disorders
Vision blurred
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Eye disorders
Visual impairment
|
0.00%
0/151 • 41 weeks
|
4.2%
2/48 • Number of events 2 • 41 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
9/151 • Number of events 14 • 41 weeks
|
4.2%
2/48 • Number of events 3 • 41 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
4.0%
6/151 • Number of events 6 • 41 weeks
|
2.1%
1/48 • Number of events 2 • 41 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.0%
3/151 • Number of events 4 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/151 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
|
Investigations
Weight decreased
|
1.3%
2/151 • Number of events 4 • 41 weeks
|
6.2%
3/48 • Number of events 4 • 41 weeks
|
|
Investigations
White blood cell count decreased
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
General disorders
Xerosis
|
0.66%
1/151 • Number of events 1 • 41 weeks
|
0.00%
0/48 • 41 weeks
|
|
Infections and infestations
Zika virus infection
|
1.3%
2/151 • Number of events 2 • 41 weeks
|
2.1%
1/48 • Number of events 1 • 41 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place