Trial Outcomes & Findings for A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation (NCT NCT01807923)
NCT ID: NCT01807923
Last Updated: 2015-08-31
Results Overview
Absolute change from baseline at Week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
559 participants
Primary outcome timeframe
Baseline, Week 16 and 24
Results posted on
2015-08-31
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Overall Study
STARTED
|
187
|
185
|
187
|
|
Overall Study
COMPLETED
|
182
|
179
|
176
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
|
Overall Study
Withdrawal of Consent (not due to AE)
|
0
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Not Eligible (Genotype)
|
0
|
0
|
1
|
|
Overall Study
Randomized But Not Treated
|
3
|
2
|
5
|
Baseline Characteristics
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
Baseline characteristics by cohort
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=183 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=182 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
Total
n=549 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.0 years
STANDARD_DEVIATION 10.80 • n=93 Participants
|
24.7 years
STANDARD_DEVIATION 9.71 • n=4 Participants
|
25.5 years
STANDARD_DEVIATION 10.09 • n=27 Participants
|
25.1 years
STANDARD_DEVIATION 10.20 • n=483 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
254 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
295 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16 and 24Population: Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
Absolute change from baseline at Week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.
Outcome measures
| Measure |
Placebo
n=180 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=176 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=172 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24
|
-0.44 percent predicted of FEV1
Standard Error 0.524
|
3.59 percent predicted of FEV1
Standard Error 0.525
|
2.16 percent predicted of FEV1
Standard Error 0.530
|
SECONDARY outcome
Timeframe: Baseline, Week 16 and 24Population: FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
Assessed as the average treatment effect at Week 16 and at Week 24. FEV1 and percent predicted FEV1 are defined in Outcome Measure (OM) 1.
Outcome measures
| Measure |
Placebo
n=180 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=176 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=172 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Relative Change From Baseline in Percent Predicted FEV1 at Week 24
|
-0.34 percent change
Standard Error 0.913
|
6.39 percent change
Standard Error 0.914
|
3.99 percent change
Standard Error 0.923
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
BMI was defined as weight in kilogram (kg) divided by height\*height in square meter (m\^2).
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=178 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=176 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Absolute Change From Baseline in Body Mass Index (BMI) at Week 24
|
0.19 kilogram per square meter (kg/m^2)
Standard Error 0.070
|
0.35 kilogram per square meter (kg/m^2)
Standard Error 0.070
|
0.32 kilogram per square meter (kg/m^2)
Standard Error 0.071
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=176 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=172 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24
|
1.10 units on a scale
Standard Error 1.161
|
4.98 units on a scale
Standard Error 1.178
|
2.60 units on a scale
Standard Error 1.192
|
SECONDARY outcome
Timeframe: Week 16 and 24Population: FAS.
A participant was considered as a responder if the participant had \>=5% increase from baseline in average percent predicted FEV1 at Week 16 and at Week 24 (relative change). FEV1 and percent predicted FEV1 are defined in OM 1. A participant with a missing average relative change from baseline in percent predicted FEV1 at Week 16 and at Week 24 was considered as a non-responder.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=183 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=182 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Percentage of Participants With Response Based on Percent Predicted FEV1
|
22.3 percentage of participants
|
46.4 percentage of participants
|
36.8 percentage of participants
|
SECONDARY outcome
Timeframe: through Week 24Population: FAS.
The total number of days on study is equal to the Week 24 date or the last dose date (whichever occurred last) minus the first dose date plus 1. The total number of years (48 weeks) on study is equal to the number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=183 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=182 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Number of Pulmonary Exacerbation Events
|
1.07 pulmonary exacerbation events per year
|
0.77 pulmonary exacerbation events per year
|
0.71 pulmonary exacerbation events per year
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=178 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=176 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Absolute Change From Baseline in Weight at Week 24
|
0.93 kilograms (kg)
Standard Error 0.202
|
1.34 kilograms (kg)
Standard Error 0.205
|
1.23 kilograms (kg)
Standard Error 0.205
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Only participants who were \<20 years of age were analyzed.
Z-Score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to + infinity; 0: same mean, \>0: a greater mean, and \<0: a lesser mean than the standard. BMI-for-age z-score was calculated by using Centers for Disease Control and Prevention (CDC) growth charts for the pediatric population.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=65 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=58 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Absolute Change From Baseline in BMI-for-age Z-score at Week 24
|
0.0153 z-score
Standard Error 0.04886
|
0.1132 z-score
Standard Error 0.05081
|
0.0933 z-score
Standard Error 0.05431
|
SECONDARY outcome
Timeframe: through Week 24Population: FAS.
Time to first pulmonary exacerbation was assessed using Cox Regression. For participants who completed 24 weeks of treatment, participants without a pulmonary exacerbation before treatment completion were considered censored at the time of treatment completion or at the Week 24 Visit (whichever occurred last). For participants who prematurely discontinued study treatment, participants without a pulmonary exacerbation through the Week 24 Visit were considered censored at the time of the Week 24 Visit.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=183 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=182 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Time-to-First Pulmonary Exacerbation
|
NA days
Median time was not reached as less than 50% of participants had the event of interest.
|
NA days
Median time was not reached as less than 50% of participants had the event of interest.
|
NA days
Median time was not reached as less than 50% of participants had the event of interest.
|
SECONDARY outcome
Timeframe: through Week 24Population: FAS.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=183 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=182 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Percentage of Participants With At Least 1 Pulmonary Exacerbation Event
|
39.7 percentage of participants
|
30.1 percentage of participants
|
30.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
EQ-5D-3L: participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The 5 dimensional 3-level systems are converted into a single index utility score. Values for theoretically possible health states are calculated using a regression model and weighted according to the social preferences of the Unites States (US) general population. For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.
Outcome measures
| Measure |
Placebo
n=179 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=175 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=170 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Absolute Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24
|
0.0006 units on a scale
Standard Error 0.00739
|
0.0066 units on a scale
Standard Error 0.00746
|
0.0100 units on a scale
Standard Error 0.00757
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
The EQ-5D-3L VAS records the participant's self-rated health on a vertical, visual analogue scale where the best state a participant can imagine is marked 100 and the worst state a participant can imagine is marked 0, higher scores indicates a better health state.
Outcome measures
| Measure |
Placebo
n=180 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=173 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=171 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Absolute Change From Baseline in EQ-5D-3L VAS Score at Week 24
|
1.4 units on a scale
Standard Error 1.03
|
3.5 units on a scale
Standard Error 1.04
|
2.8 units on a scale
Standard Error 1.04
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS. Here, "n" signifies participants who were evaluable for specified category for each arm, respectively.
The TSQM is a 14-item self-administered questionnaire which measures participants' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=183 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=182 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24
Effectiveness (n = 163, 156, 144)
|
-5.30 units on a scale
Standard Error 1.643
|
0.19 units on a scale
Standard Error 1.666
|
0.50 units on a scale
Standard Error 1.726
|
|
Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24
Side Effects (n = 162, 154, 143)
|
2.23 units on a scale
Standard Error 1.119
|
-1.94 units on a scale
Standard Error 1.141
|
-2.51 units on a scale
Standard Error 1.179
|
|
Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24
Convenience (n = 163, 154, 144)
|
4.37 units on a scale
Standard Error 1.504
|
4.98 units on a scale
Standard Error 1.540
|
7.45 units on a scale
Standard Error 1.579
|
|
Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24
Global Satisfaction (n= 163, 154, 144)
|
-10.49 units on a scale
Standard Error 1.863
|
-5.00 units on a scale
Standard Error 1.906
|
-3.77 units on a scale
Standard Error 1.956
|
SECONDARY outcome
Timeframe: up to Week 28Population: Safety Set (SS) included all randomized participants who received any amount of study drug.
AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Nonserious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or that was newly developed at or after the initial dosing of study drug to 28 days after the last dose of study drug is considered treatment-emergent.
Outcome measures
| Measure |
Placebo
n=184 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=183 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=182 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Treatment-Emergent Adverse Events (SAEs)
Participants With Treatment-Emergent AEs
|
174 participants
|
175 participants
|
174 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Treatment-Emergent Adverse Events (SAEs)
Participants With Treatment-Emergent SAEs
|
49 participants
|
33 participants
|
33 participants
|
SECONDARY outcome
Timeframe: For C3-6h: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For C3-6h,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and 16Population: Pharmacokinetic (PK) population included all randomized participants who received at least one dose of study drug and had a PK assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and "n" signifies participants evaluable for specified category for each arm, respectively.
Ctrough, Ctrough, avg, C3-6h, and C3-6h, avg for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. C3-6h,ave is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough, ave is average of individual pre-dose observed concentrations across Weeks 4, 8, and 16. This outcome was not planned to be assessed in Placebo arm.
Outcome measures
| Measure |
Placebo
n=180 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=181 Participants
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM, Day 1: C3-6h (n = 180, 175)
|
27.5 microgram per milliliter (mcg/mL)
Standard Deviation 12.5
|
18.4 microgram per milliliter (mcg/mL)
Standard Deviation 8.55
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM, Day 15: Ctrough (n = 172, 175)
|
7.56 microgram per milliliter (mcg/mL)
Standard Deviation 5.33
|
14.1 microgram per milliliter (mcg/mL)
Standard Deviation 6.99
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM, Day 15: C3-6 (n = 167, 171)
|
26.1 microgram per milliliter (mcg/mL)
Standard Deviation 11.5
|
23.6 microgram per milliliter (mcg/mL)
Standard Deviation 8.54
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM, Week 4: Ctrough (n = 172, 178)
|
7.75 microgram per milliliter (mcg/mL)
Standard Deviation 5.05
|
13.4 microgram per milliliter (mcg/mL)
Standard Deviation 6.70
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM, Week 4: C3-6 (n = 170, 171)
|
28.4 microgram per milliliter (mcg/mL)
Standard Deviation 11.2
|
24.2 microgram per milliliter (mcg/mL)
Standard Deviation 8.66
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM, Week 8: Ctrough (n = 173, 174)
|
7.43 microgram per milliliter (mcg/mL)
Standard Deviation 5.60
|
13.4 microgram per milliliter (mcg/mL)
Standard Deviation 6.68
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM, Week 8: C3-6 (n = 165, 171)
|
28.2 microgram per milliliter (mcg/mL)
Standard Deviation 11.2
|
24.4 microgram per milliliter (mcg/mL)
Standard Deviation 8.80
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM, Week 16: Ctrough (n = 165, 164)
|
6.95 microgram per milliliter (mcg/mL)
Standard Deviation 4.99
|
13.5 microgram per milliliter (mcg/mL)
Standard Deviation 7.49
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM, Day 1: C3-6h (n = 180, 175)
|
0.220 microgram per milliliter (mcg/mL)
Standard Deviation 0.107
|
0.179 microgram per milliliter (mcg/mL)
Standard Deviation 0.0811
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM, Day 15: Ctrough (n = 172, 175)
|
1.25 microgram per milliliter (mcg/mL)
Standard Deviation 0.614
|
1.48 microgram per milliliter (mcg/mL)
Standard Deviation 0.590
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM, Day 15: C3-6 (n = 167, 171)
|
1.37 microgram per milliliter (mcg/mL)
Standard Deviation 0.606
|
1.49 microgram per milliliter (mcg/mL)
Standard Deviation 0.576
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM, Week 4: Ctrough (n = 172, 178)
|
1.31 microgram per milliliter (mcg/mL)
Standard Deviation 0.646
|
1.48 microgram per milliliter (mcg/mL)
Standard Deviation 0.642
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM, Week 4: C3-6 (n = 170, 171)
|
1.39 microgram per milliliter (mcg/mL)
Standard Deviation 0.635
|
1.49 microgram per milliliter (mcg/mL)
Standard Deviation 0.615
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM, Week 8: Ctrough (n = 173, 174)
|
1.32 microgram per milliliter (mcg/mL)
Standard Deviation 0.684
|
1.53 microgram per milliliter (mcg/mL)
Standard Deviation 0.674
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM, Week 8: C3-6 (n = 165, 171)
|
1.42 microgram per milliliter (mcg/mL)
Standard Deviation 0.658
|
1.56 microgram per milliliter (mcg/mL)
Standard Deviation 0.669
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM, Week 16: Ctrough (n = 165, 164)
|
1.30 microgram per milliliter (mcg/mL)
Standard Deviation 0.769
|
1.57 microgram per milliliter (mcg/mL)
Standard Deviation 0.757
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA, Day 1: C3-6h (n = 180, 175)
|
1.29 microgram per milliliter (mcg/mL)
Standard Deviation 0.624
|
1.24 microgram per milliliter (mcg/mL)
Standard Deviation 0.630
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA, Day 15: Ctrough (n = 172, 176)
|
0.151 microgram per milliliter (mcg/mL)
Standard Deviation 0.123
|
0.115 microgram per milliliter (mcg/mL)
Standard Deviation 0.123
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA, Day 15: C3-6 (n = 167, 171)
|
0.557 microgram per milliliter (mcg/mL)
Standard Deviation 0.311
|
0.413 microgram per milliliter (mcg/mL)
Standard Deviation 0.199
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA, Week 4: Ctrough (n = 172, 178)
|
0.142 microgram per milliliter (mcg/mL)
Standard Deviation 0.107
|
0.105 microgram per milliliter (mcg/mL)
Standard Deviation 0.083
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA, Week 4: C3-6 (n = 170, 171)
|
0.638 microgram per milliliter (mcg/mL)
Standard Deviation 0.325
|
0.456 microgram per milliliter (mcg/mL)
Standard Deviation 0.235
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA, Week 8: Ctrough (n = 173, 174)
|
0.130 microgram per milliliter (mcg/mL)
Standard Deviation 0.101
|
0.0894 microgram per milliliter (mcg/mL)
Standard Deviation 0.0726
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA, Week 8: C3-6 (n = 165, 171)
|
0.648 microgram per milliliter (mcg/mL)
Standard Deviation 0.364
|
0.470 microgram per milliliter (mcg/mL)
Standard Deviation 0.295
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA, Week 16: Ctrough (n = 165, 164)
|
0.133 microgram per milliliter (mcg/mL)
Standard Deviation 0.131
|
0.0834 microgram per milliliter (mcg/mL)
Standard Deviation 0.0622
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-1 IVA, Day 1: C3-6h (n = 180, 175)
|
2.46 microgram per milliliter (mcg/mL)
Standard Deviation 1.29
|
2.41 microgram per milliliter (mcg/mL)
Standard Deviation 1.35
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-1 IVA, Day 15: Ctrough (n = 172, 176)
|
0.665 microgram per milliliter (mcg/mL)
Standard Deviation 0.578
|
0.511 microgram per milliliter (mcg/mL)
Standard Deviation 0.530
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-1 IVA, Day 15: C3-6 (n = 167, 171)
|
1.94 microgram per milliliter (mcg/mL)
Standard Deviation 0.981
|
1.71 microgram per milliliter (mcg/mL)
Standard Deviation 0.867
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-1 IVA, Week 4: Ctrough (n = 172, 178)
|
0.628 microgram per milliliter (mcg/mL)
Standard Deviation 0.492
|
0.450 microgram per milliliter (mcg/mL)
Standard Deviation 0.345
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-1 IVA, Week 4: C3-6 (n = 170, 171)
|
2.21 microgram per milliliter (mcg/mL)
Standard Deviation 1.01
|
1.76 microgram per milliliter (mcg/mL)
Standard Deviation 0.932
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-1 IVA, Week 8: Ctrough (n = 173, 174)
|
0.584 microgram per milliliter (mcg/mL)
Standard Deviation 0.451
|
0.404 microgram per milliliter (mcg/mL)
Standard Deviation 0.381
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-1 IVA, Week 8: C3-6 (n = 165, 171)
|
2.17 microgram per milliliter (mcg/mL)
Standard Deviation 1.06
|
1.78 microgram per milliliter (mcg/mL)
Standard Deviation 0.975
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-1 IVA, Week 16: Ctrough (n = 165, 164)
|
0.589 microgram per milliliter (mcg/mL)
Standard Deviation 0.519
|
0.396 microgram per milliliter (mcg/mL)
Standard Deviation 0.319
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-6 IVA, Day 1: C3-6h (n = 180, 175)
|
0.976 microgram per milliliter (mcg/mL)
Standard Deviation 0.877
|
0.927 microgram per milliliter (mcg/mL)
Standard Deviation 0.875
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-6 IVA, Day 15: Ctrough (n = 172, 176)
|
1.68 microgram per milliliter (mcg/mL)
Standard Deviation 1.31
|
1.67 microgram per milliliter (mcg/mL)
Standard Deviation 1.40
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-6 IVA, Day 15: C3-6 (n = 167, 171)
|
3.03 microgram per milliliter (mcg/mL)
Standard Deviation 1.96
|
2.87 microgram per milliliter (mcg/mL)
Standard Deviation 1.81
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-6 IVA, Week 4: Ctrough (n = 172, 178)
|
1.66 microgram per milliliter (mcg/mL)
Standard Deviation 1.36
|
1.46 microgram per milliliter (mcg/mL)
Standard Deviation 0.938
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-6 IVA, Week 4: C3-6 (n = 170, 171)
|
3.07 microgram per milliliter (mcg/mL)
Standard Deviation 1.92
|
2.49 microgram per milliliter (mcg/mL)
Standard Deviation 1.53
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-6 IVA, Week 8: Ctrough (n = 173, 174)
|
1.52 microgram per milliliter (mcg/mL)
Standard Deviation 1.12
|
1.31 microgram per milliliter (mcg/mL)
Standard Deviation 0.946
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-6 IVA, Week 8: C3-6 (n = 165, 171)
|
2.96 microgram per milliliter (mcg/mL)
Standard Deviation 1.86
|
2.36 microgram per milliliter (mcg/mL)
Standard Deviation 1.57
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-6 IVA, Week 16: Ctrough (n = 165, 164)
|
1.40 microgram per milliliter (mcg/mL)
Standard Deviation 1.11
|
1.33 microgram per milliliter (mcg/mL)
Standard Deviation 1.02
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM: Ctrough,ave (n = 179, 181)
|
7.49 microgram per milliliter (mcg/mL)
Standard Deviation 3.93
|
13.5 microgram per milliliter (mcg/mL)
Standard Deviation 5.52
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
LUM: C3-6h,ave (n = 179, 181)
|
27.7 microgram per milliliter (mcg/mL)
Standard Deviation 8.63
|
24.0 microgram per milliliter (mcg/mL)
Standard Deviation 7.29
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM: Ctrough,ave (n = 179, 181)
|
1.31 microgram per milliliter (mcg/mL)
Standard Deviation 0.628
|
1.51 microgram per milliliter (mcg/mL)
Standard Deviation 0.614
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M-28 LUM: C3-6h,ave (n = 179, 181)
|
1.39 microgram per milliliter (mcg/mL)
Standard Deviation 0.596
|
1.51 microgram per milliliter (mcg/mL)
Standard Deviation 0.585
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA: Ctrough,ave (n = 179, 181)
|
0.137 microgram per milliliter (mcg/mL)
Standard Deviation 0.0773
|
0.0989 microgram per milliliter (mcg/mL)
Standard Deviation 0.0644
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
IVA: C3-6h,ave (n = 179, 181)
|
0.614 microgram per milliliter (mcg/mL)
Standard Deviation 0.271
|
0.445 microgram per milliliter (mcg/mL)
Standard Deviation 0.193
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M1-IVA: Ctrough,ave (n = 179, 181)
|
0.606 microgram per milliliter (mcg/mL)
Standard Deviation 0.350
|
0.441 microgram per milliliter (mcg/mL)
Standard Deviation 0.293
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M1-IVA: C3-6h,ave (n = 179, 181)
|
2.11 microgram per milliliter (mcg/mL)
Standard Deviation 0.817
|
1.74 microgram per milliliter (mcg/mL)
Standard Deviation 0.726
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M6-IVA: Ctrough,ave (n = 179, 181)
|
1.57 microgram per milliliter (mcg/mL)
Standard Deviation 0.992
|
1.44 microgram per milliliter (mcg/mL)
Standard Deviation 0.861
|
—
|
|
Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)
M6-IVA: C3-6h,ave (n = 179, 181)
|
3.04 microgram per milliliter (mcg/mL)
Standard Deviation 1.55
|
2.57 microgram per milliliter (mcg/mL)
Standard Deviation 1.34
|
—
|
Adverse Events
Placebo
Serious events: 49 serious events
Other events: 173 other events
Deaths: 0 deaths
LUM 600 mg qd/IVA 250 mg q12h
Serious events: 33 serious events
Other events: 175 other events
Deaths: 0 deaths
LUM 400 mg q12h/ IVA 250 mg q12h
Serious events: 33 serious events
Other events: 172 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=184 participants at risk
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=183 participants at risk
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=182 participants at risk
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
22.3%
41/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
10.4%
19/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.3%
17/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Influenza
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Tracheobronchitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Appendicitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bronchopneumonia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Lung infection
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Implant site thrombosis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Device dislocation
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
Other adverse events
| Measure |
Placebo
n=184 participants at risk
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=183 participants at risk
LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
|
LUM 400 mg q12h/ IVA 250 mg q12h
n=182 participants at risk
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
31.5%
58/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
31.1%
57/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
29.7%
54/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
20/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.9%
9/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
14.3%
26/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
10/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
8.7%
16/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.3%
17/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.5%
12/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
8.2%
15/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.1%
13/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Rhinitis
|
6.5%
12/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
8.7%
16/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.4%
8/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Sinusitis
|
6.5%
12/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Influenza
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.4%
8/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.4%
8/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bronchitis
|
3.8%
7/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.9%
9/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Pharyngitis
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Oral candidiasis
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Viral infection
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Gastroenteritis viral
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
H1N1 influenza
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Oral herpes
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Otitis media
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Acute sinusitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Fungal skin infection
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Laryngitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bacterial disease carrier
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Mycobacterium abscessus infection
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Tonsillitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Acute tonsillitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Body tinea
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Ear infection
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Eye infection
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Lung infection
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Oral fungal infection
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Overgrowth bacterial
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Pseudomonas bronchitis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Tooth infection
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Viral tonsillitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.9%
66/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
28.4%
52/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
25.8%
47/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
12.5%
23/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
12.0%
22/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
14.3%
26/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
12.5%
23/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
8.2%
15/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
13.7%
25/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.6%
14/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
11.5%
21/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.3%
17/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
4.9%
9/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
14.2%
26/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.7%
14/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.6%
25/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.9%
9/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
6.0%
11/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
10/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
13.1%
24/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
6.0%
11/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.7%
5/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.5%
10/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.3%
6/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
3.8%
7/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.7%
5/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Lung hyperinflation
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal exudate
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged expiration
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract irritation
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
13/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
8.7%
16/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
13.2%
24/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
12/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
6.0%
11/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
12.6%
23/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
11/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.9%
9/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.7%
14/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
11/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
10/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Flatulence
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.9%
9/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
6.0%
11/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.4%
8/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Enteritis
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Toothache
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Anal fissure
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Colonic haematoma
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Faecaloma
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gingivitis ulcerative
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Tongue coated
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.4%
10/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.5%
10/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.1%
13/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Bacterial test positive
|
4.9%
9/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
5/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Forced expiratory volume decreased
|
3.8%
7/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Weight decreased
|
2.7%
5/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Liver function test abnormal
|
3.3%
6/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Pulmonary function test decreased
|
3.3%
6/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood creatinine increased
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
White blood cell count increased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood glucose decreased
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Vitamin D decreased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Breath sounds abnormal
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Fungal test positive
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Transaminases increased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood glucose increased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood immunoglobulin E increased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood phosphorus increased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Body temperature increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Atypical mycobacterium test positive
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood bicarbonate decreased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood calcium increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood phosphorus abnormal
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood potassium increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood urea increased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Forced expiratory volume increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Glucose tolerance test abnormal
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Glucose urine present
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Heart rate increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Platelet count decreased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Pseudomonas test positive
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Sputum abnormal
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Urine calcium increased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Vitamin E decreased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Fatigue
|
10.3%
19/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.3%
17/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.3%
17/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Pyrexia
|
6.5%
12/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
6.6%
12/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.3%
17/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Asthenia
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Pain
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Chest discomfort
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Malaise
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Chills
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Drug intolerance
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Chest pain
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Influenza like illness
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Drug interaction
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Feeling abnormal
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Feeling cold
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Feeling hot
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Hyperthermia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Implant site thrombosis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Local swelling
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Medical device pain
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Oedema peripheral
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Headache
|
13.6%
25/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
15.3%
28/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
15.9%
29/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Dizziness
|
2.7%
5/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Sinus headache
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Migraine
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Lethargy
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Dysgeusia
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Syncope
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Tremor
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Ataxia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Presyncope
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Sciatica
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Somnolence
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.3%
6/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
5/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.4%
8/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.7%
5/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Chloasma
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.3%
6/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
3/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Stoma site erythema
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Insomnia
|
3.3%
6/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Anxiety
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Depression
|
2.2%
4/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Irritability
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Bradyphrenia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Disturbance in social behaviour
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Emotional disorder
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Libido decreased
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Middle insomnia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Penile erythema
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Ear and labyrinth disorders
Ear pain
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Ear and labyrinth disorders
Ear canal erythema
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Vision blurred
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Asthenopia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Astigmatism
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Conjunctivitis allergic
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Eye disorder
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Urine odour abnormal
|
1.1%
2/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Leukocyturia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Hot flush
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Hypotension
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Poor venous access
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Palpitations
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Immune system disorders
Seasonal allergy
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Immune system disorders
Anaphylactic reaction
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Immune system disorders
Hypersensitivity
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Hepatobiliary disorders
Hepatitis
|
0.54%
1/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/184 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.55%
1/183 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/182 • Up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
- Publication restrictions are in place
Restriction type: OTHER