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 NCT01807949)
NCT ID: NCT01807949
Last Updated: 2016-09-27
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
563 participants
Primary outcome timeframe
Baseline, Week 16 and 24
Results posted on
2016-09-27
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
|
187
|
189
|
|
Overall Study
COMPLETED
|
185
|
180
|
180
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
9
|
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
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
|
Overall Study
Non-Compliance
|
0
|
0
|
1
|
|
Overall Study
Undefined
|
0
|
1
|
2
|
|
Overall Study
Randomized But Not Treated
|
0
|
2
|
2
|
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=187 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=185 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=187 Participants
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
Total
n=559 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.7 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 8.31 • n=7 Participants
|
25.0 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 9.16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
291 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
268 Participants
n=4 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=183 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
n=180 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
|
-0.15 percent predicted of FEV1
Standard Error 0.539
|
2.46 percent predicted of FEV1
Standard Error 0.540
|
2.85 percent predicted of FEV1
Standard Error 0.540
|
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=183 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
n=180 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
|
0.00 percent change
Standard Error 0.960
|
4.42 percent change
Standard Error 0.961
|
5.25 percent change
Standard Error 0.961
|
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=183 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=180 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=180 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
|
0.07 kilogram per square meter (kg/m^2)
Standard Error 0.066
|
0.48 kilogram per square meter (kg/m^2)
Standard Error 0.066
|
0.43 kilogram per square meter (kg/m^2)
Standard Error 0.066
|
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=185 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=180 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=179 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
|
2.81 units on a scale
Standard Error 1.153
|
5.02 units on a scale
Standard Error 1.166
|
5.66 units on a scale
Standard Error 1.169
|
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=187 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=185 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=187 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
|
22.5 percentage of participants
|
45.9 percentage of participants
|
41.2 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=187 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=185 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=187 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
|
1.18 pulmonary exacerbation events per year
|
0.82 pulmonary exacerbation events per year
|
0.67 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=183 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=180 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=180 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
|
0.44 kilograms (kg)
Standard Error 0.187
|
1.57 kilograms (kg)
Standard Error 0.188
|
1.38 kilograms (kg)
Standard Error 0.187
|
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=53 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=54 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
|
-0.0674 z-score
Standard Error 0.04706
|
0.1640 z-score
Standard Error 0.04652
|
0.1544 z-score
Standard Error 0.04513
|
SECONDARY outcome
Timeframe: through Week 24Population: FAS.
Time to first pulmonary exacerbation was assessed using Cox Regression method. 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=187 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=185 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=187 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=187 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=185 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=187 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
|
47.1 percentage of participants
|
36.8 percentage of participants
|
28.9 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=183 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 Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24
|
0.0117 units on a scale
Standard Error 0.00673
|
0.0090 units on a scale
Standard Error 0.00682
|
0.0108 units on a scale
Standard Error 0.00683
|
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=182 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=177 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=177 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
|
3.3 units on a scale
Standard Error 1.07
|
5.7 units on a scale
Standard Error 1.08
|
6.6 units on a scale
Standard Error 1.08
|
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=187 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=185 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=187 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 = 159, 161, 161)
|
-8.49 units on a scale
Standard Error 1.814
|
0.15 units on a scale
Standard Error 1.807
|
3.12 units on a scale
Standard Error 1.793
|
|
Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24
Side Effects (n = 157, 159, 161)
|
2.03 units on a scale
Standard Error 1.144
|
-1.14 units on a scale
Standard Error 1.137
|
-2.26 units on a scale
Standard Error 1.121
|
|
Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24
Convenience (n = 158, 160, 161)
|
4.57 units on a scale
Standard Error 1.525
|
4.57 units on a scale
Standard Error 1.523
|
4.88 units on a scale
Standard Error 1.501
|
|
Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24
Global Satisfaction (n= 158, 160, 161)
|
-9.62 units on a scale
Standard Error 1.841
|
-4.98 units on a scale
Standard Error 1.845
|
-2.46 units on a scale
Standard Error 1.814
|
SECONDARY outcome
Timeframe: up to Week 28Population: Safety Set (SS) included all randomized participants who received any amount of study drug. Participants were analyzed as per actual treatment received.
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 Non-serious 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=186 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=186 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=187 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 Treatment-Emergent Serious Adverse Events (SAEs)
Participants With Treatment-Emergent AEs
|
181 participants
|
181 participants
|
177 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Participants With Treatment-Emergent SAEs
|
57 participants
|
51 participants
|
31 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,avg is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough,avg 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=182 Participants
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=182 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 = 181, 180)
|
30.8 microgram per milliliter (mcg/mL)
Standard Deviation 12.6
|
20.2 microgram per milliliter (mcg/mL)
Standard Deviation 8.33
|
—
|
|
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: C3-6h (n = 174, 176)
|
30.4 microgram per milliliter (mcg/mL)
Standard Deviation 11.2
|
23.9 microgram per milliliter (mcg/mL)
Standard Deviation 8.87
|
—
|
|
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 = 174, 179)
|
8.11 microgram per milliliter (mcg/mL)
Standard Deviation 5.21
|
13.2 microgram per milliliter (mcg/mL)
Standard Deviation 6.28
|
—
|
|
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: C3-6h (n = 164, 168)
|
29.2 microgram per milliliter (mcg/mL)
Standard Deviation 12.1
|
24.5 microgram per milliliter (mcg/mL)
Standard Deviation 8.75
|
—
|
|
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 = 177, 177)
|
7.87 microgram per milliliter (mcg/mL)
Standard Deviation 5.71
|
12.4 microgram per milliliter (mcg/mL)
Standard Deviation 6.87
|
—
|
|
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: C3-6h (n = 174, 170)
|
30.4 microgram per milliliter (mcg/mL)
Standard Deviation 11.6
|
24.9 microgram per milliliter (mcg/mL)
Standard Deviation 9.79
|
—
|
|
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 = 171, 173)
|
7.53 microgram per milliliter (mcg/mL)
Standard Deviation 6.05
|
12.2 microgram per milliliter (mcg/mL)
Standard Deviation 6.87
|
—
|
|
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 = 181, 180)
|
0.226 microgram per milliliter (mcg/mL)
Standard Deviation 0.103
|
0.181 microgram per milliliter (mcg/mL)
Standard Deviation 0.0790
|
—
|
|
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: C3-6h (n = 174, 176)
|
1.43 microgram per milliliter (mcg/mL)
Standard Deviation 0.588
|
1.39 microgram per milliliter (mcg/mL)
Standard Deviation 0.606
|
—
|
|
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 = 174, 179)
|
1.32 microgram per milliliter (mcg/mL)
Standard Deviation 0.680
|
1.42 microgram per milliliter (mcg/mL)
Standard Deviation 0.661
|
—
|
|
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: C3-6h (n = 164, 168)
|
1.39 microgram per milliliter (mcg/mL)
Standard Deviation 0.657
|
1.45 microgram per milliliter (mcg/mL)
Standard Deviation 0.675
|
—
|
|
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 = 177, 177)
|
1.34 microgram per milliliter (mcg/mL)
Standard Deviation 0.714
|
1.44 microgram per milliliter (mcg/mL)
Standard Deviation 0.722
|
—
|
|
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: C3-6h (n = 174, 170)
|
1.41 microgram per milliliter (mcg/mL)
Standard Deviation 0.702
|
1.48 microgram per milliliter (mcg/mL)
Standard Deviation 0.711
|
—
|
|
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 = 171, 173)
|
1.27 microgram per milliliter (mcg/mL)
Standard Deviation 0.763
|
1.43 microgram per milliliter (mcg/mL)
Standard Deviation 0.775
|
—
|
|
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 = 181, 180)
|
1.34 microgram per milliliter (mcg/mL)
Standard Deviation 0.643
|
1.36 microgram per milliliter (mcg/mL)
Standard Deviation 0.647
|
—
|
|
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: C3-6h (n = 174, 176)
|
0.647 microgram per milliliter (mcg/mL)
Standard Deviation 0.492
|
0.469 microgram per milliliter (mcg/mL)
Standard Deviation 0.282
|
—
|
|
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 = 174, 179)
|
0.164 microgram per milliliter (mcg/mL)
Standard Deviation 0.207
|
0.108 microgram per milliliter (mcg/mL)
Standard Deviation 0.112
|
—
|
|
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: C3-6h (n = 164, 168)
|
0.636 microgram per milliliter (mcg/mL)
Standard Deviation 0.380
|
0.473 microgram per milliliter (mcg/mL)
Standard Deviation 0.239
|
—
|
|
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 = 177, 177)
|
0.182 microgram per milliliter (mcg/mL)
Standard Deviation 0.293
|
0.102 microgram per milliliter (mcg/mL)
Standard Deviation 0.130
|
—
|
|
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: C3-6h (n = 174, 170)
|
0.710 microgram per milliliter (mcg/mL)
Standard Deviation 0.567
|
0.513 microgram per milliliter (mcg/mL)
Standard Deviation 0.277
|
—
|
|
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 = 171, 173)
|
0.163 microgram per milliliter (mcg/mL)
Standard Deviation 0.237
|
0.113 microgram per milliliter (mcg/mL)
Standard Deviation 0.218
|
—
|
|
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 = 181, 180)
|
2.51 microgram per milliliter (mcg/mL)
Standard Deviation 1.30
|
2.65 microgram per milliliter (mcg/mL)
Standard Deviation 1.29
|
—
|
|
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-1 IVA, Day 15: C3-6h (n = 174, 176)
|
2.21 microgram per milliliter (mcg/mL)
Standard Deviation 1.08
|
1.85 microgram per milliliter (mcg/mL)
Standard Deviation 0.860
|
—
|
|
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 = 174, 179)
|
0.676 microgram per milliliter (mcg/mL)
Standard Deviation 0.612
|
0.501 microgram per milliliter (mcg/mL)
Standard Deviation 0.455
|
—
|
|
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: C3-6h (n = 164, 168)
|
2.11 microgram per milliliter (mcg/mL)
Standard Deviation 1.12
|
1.88 microgram per milliliter (mcg/mL)
Standard Deviation 0.953
|
—
|
|
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 = 177, 177)
|
0.672 microgram per milliliter (mcg/mL)
Standard Deviation 0.704
|
0.463 microgram per milliliter (mcg/mL)
Standard Deviation 0.495
|
—
|
|
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: C3-6h (n = 174, 170)
|
2.15 microgram per milliliter (mcg/mL)
Standard Deviation 1.19
|
1.91 microgram per milliliter (mcg/mL)
Standard Deviation 0.910
|
—
|
|
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 = 171, 173)
|
0.643 microgram per milliliter (mcg/mL)
Standard Deviation 0.594
|
0.465 microgram per milliliter (mcg/mL)
Standard Deviation 0.449
|
—
|
|
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 = 181, 180)
|
0.993 microgram per milliliter (mcg/mL)
Standard Deviation 0.820
|
0.996 microgram per milliliter (mcg/mL)
Standard Deviation 0.797
|
—
|
|
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: C3-6h (n = 174, 176)
|
3.62 microgram per milliliter (mcg/mL)
Standard Deviation 2.18
|
2.99 microgram per milliliter (mcg/mL)
Standard Deviation 1.68
|
—
|
|
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)
M-6 IVA, Week 4: Ctrough (n = 174, 179)
|
1.73 microgram per milliliter (mcg/mL)
Standard Deviation 1.34
|
1.64 microgram per milliliter (mcg/mL)
Standard Deviation 1.20
|
—
|
|
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: C3-6h (n = 164, 168)
|
3.07 microgram per milliliter (mcg/mL)
Standard Deviation 1.84
|
2.64 microgram per milliliter (mcg/mL)
Standard Deviation 1.45
|
—
|
|
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 = 177, 177)
|
1.60 microgram per milliliter (mcg/mL)
Standard Deviation 1.22
|
1.47 microgram per milliliter (mcg/mL)
Standard Deviation 1.17
|
—
|
|
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: C3-6h (n = 174, 170)
|
3.00 microgram per milliliter (mcg/mL)
Standard Deviation 2.01
|
2.56 microgram per milliliter (mcg/mL)
Standard Deviation 1.48
|
—
|
|
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 = 171, 173)
|
1.51 microgram per milliliter (mcg/mL)
Standard Deviation 1.29
|
1.42 microgram per milliliter (mcg/mL)
Standard Deviation 1.05
|
—
|
|
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,avg (n = 179, 182)
|
7.81 microgram per milliliter (mcg/mL)
Standard Deviation 4.26
|
12.7 microgram per milliliter (mcg/mL)
Standard Deviation 5.60
|
—
|
|
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,avg (n = 182, 181)
|
29.9 microgram per milliliter (mcg/mL)
Standard Deviation 9.19
|
24.3 microgram per milliliter (mcg/mL)
Standard Deviation 7.72
|
—
|
|
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,avg (n = 179, 182)
|
1.31 microgram per milliliter (mcg/mL)
Standard Deviation 0.672
|
1.42 microgram per milliliter (mcg/mL)
Standard Deviation 0.676
|
—
|
|
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,avg (n = 182, 181)
|
1.41 microgram per milliliter (mcg/mL)
Standard Deviation 0.620
|
1.43 microgram per milliliter (mcg/mL)
Standard Deviation 0.640
|
—
|
|
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,avg (n = 179, 182)
|
0.170 microgram per milliliter (mcg/mL)
Standard Deviation 0.196
|
0.110 microgram per milliliter (mcg/mL)
Standard Deviation 0.124
|
—
|
|
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,avg (n = 182, 181)
|
0.668 microgram per milliliter (mcg/mL)
Standard Deviation 0.392
|
0.484 microgram per milliliter (mcg/mL)
Standard Deviation 0.210
|
—
|
|
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,avg (n = 179, 182)
|
0.660 microgram per milliliter (mcg/mL)
Standard Deviation 0.504
|
0.484 microgram per milliliter (mcg/mL)
Standard Deviation 0.391
|
—
|
|
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,avg (n = 182, 181)
|
2.14 microgram per milliliter (mcg/mL)
Standard Deviation 0.951
|
1.87 microgram per milliliter (mcg/mL)
Standard Deviation 0.710
|
—
|
|
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,avg (n = 179, 182)
|
1.60 microgram per milliliter (mcg/mL)
Standard Deviation 1.08
|
1.50 microgram per milliliter (mcg/mL)
Standard Deviation 0.897
|
—
|
|
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,avg (n = 182, 181)
|
3.18 microgram per milliliter (mcg/mL)
Standard Deviation 1.65
|
2.70 microgram per milliliter (mcg/mL)
Standard Deviation 1.23
|
—
|
Adverse Events
Placebo
Serious events: 57 serious events
Other events: 181 other events
Deaths: 0 deaths
LUM 600 mg qd/IVA 250 mg q12h
Serious events: 51 serious events
Other events: 179 other events
Deaths: 0 deaths
LUM 400 mg q12h/ IVA 250 mg q12h
Serious events: 31 serious events
Other events: 175 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=186 participants at risk
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=186 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=187 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
|
25.8%
48/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
19.4%
36/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
12.8%
24/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bronchitis
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 fungal
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Viraemia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 cavitation
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Bacterial test positive
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Proteinuria
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Medical device complication
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Suture related complication
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Suicidal ideation
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Suicide attempt
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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=186 participants at risk
Placebo matched to LUM and IVA tablet q12h, up to Week 24.
|
LUM 600 mg qd/IVA 250 mg q12h
n=186 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=187 participants at risk
LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.1%
82/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
37.1%
69/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
29.9%
56/187 • 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
|
25.3%
47/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
21.5%
40/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
15.5%
29/187 • 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
|
8.1%
15/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
17.2%
32/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
16.6%
31/187 • 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
|
14.0%
26/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
15.1%
28/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
10.7%
20/187 • 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
|
10.2%
19/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
12.9%
24/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.0%
13/187 • 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
|
10.8%
20/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
10.8%
20/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.0%
13/187 • 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
|
7.0%
13/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.5%
14/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.6%
18/187 • 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
|
5.4%
10/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.9%
11/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.9%
11/187 • 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
|
7.5%
14/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.9%
11/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/187 • 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
|
5.9%
11/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.3%
8/187 • 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
|
3.2%
6/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.8%
9/187 • 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
|
4.8%
9/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.2%
6/187 • 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
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.2%
6/187 • 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
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.7%
7/187 • 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
|
3.2%
6/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
3.2%
6/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 discharge discolouration
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 decreased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 secretion retention
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Hiccups
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Hyperventilation
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 bronchial secretion
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 discomfort
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 oedema
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Pleurisy
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Pneumonitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 disorder
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 gas exchange disorder
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 disorder
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 congestion
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
39.8%
74/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
31.2%
58/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
26.7%
50/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Nasopharyngitis
|
10.8%
20/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.5%
14/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
11.8%
22/187 • 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%
10/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
10.7%
20/187 • 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
|
7.0%
13/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.0%
13/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.3%
10/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Sinusitis
|
3.8%
7/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.1%
17/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.9%
11/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Rhinitis
|
3.2%
6/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.5%
14/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.3%
8/187 • 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%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.2%
6/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.9%
11/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Gastroenteritis
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.1%
4/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Pharyngitis
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bronchitis
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 bacterial
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Infectious mononucleosis
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Rash pustular
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Bronchitis viral
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Cystitis
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Device related infection
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Eyelid infection
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Gynaecological chlamydia infection
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Infected bites
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Infusion site infection
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Localised infection
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Nipple infection
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Tooth abscess
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
17/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
10.8%
20/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
17.1%
32/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
18/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
10.8%
20/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
11.2%
21/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.2%
19/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
8.1%
15/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.3%
10/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Flatulence
|
5.4%
10/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
5.9%
11/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.0%
13/187 • 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
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
8.1%
15/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.7%
7/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
9/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
6.5%
12/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.8%
9/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.2%
6/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.2%
6/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.7%
7/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.2%
6/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Steatorrhoea
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Eructation
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Gastrointestinal tract irritation
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Odynophagia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Oral pain
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Headache
|
17.7%
33/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
16.1%
30/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
15.5%
29/187 • 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
|
3.8%
7/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
8.1%
15/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.7%
7/187 • 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%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Lethargy
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Migraine
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Tremor
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Amnesia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Paraesthesia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Parosmia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Hyposmia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Loss of consciousness
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Nerve compression
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Pyrexia
|
11.8%
22/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
11.8%
22/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
8.6%
16/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Fatigue
|
5.4%
10/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
7.0%
13/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.1%
17/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Chest discomfort
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.1%
4/187 • 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%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Chills
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Chest pain
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Thirst
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Sensation of foreign body
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Application site pruritus
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Application site rash
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Asthenia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Device occlusion
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Energy increased
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Feeling jittery
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Infusion site pain
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Local swelling
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Oedema peripheral
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Application site irritation
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Application site reaction
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Device leakage
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Device malfunction
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Discomfort
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Infusion site bruising
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Injection site erythema
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Injection site pain
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Injection site warmth
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Medical device complication
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Thrombosis in device
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
10/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
6.4%
12/187 • 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
|
7.5%
14/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Bacterial test positive
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.7%
7/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.1%
4/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Weight decreased
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Sputum abnormal
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood creatinine increased
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Haemoglobin decreased
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood calcium increased
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood iron decreased
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood pressure increased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood sodium increased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Blood urine present
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Crystal urine present
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Electrocardiogram PR shortened
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Haemophilus test positive
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Mean cell volume increased
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 decreased
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Serum ferritin decreased
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Transaminases increased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Investigations
Weight increased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
9.6%
18/187 • 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
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Onychoclasis
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 pruritic
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Skin odour abnormal
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Blister
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Cutaneous lupus erythematosus
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Hair texture abnormal
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Hyperkeratosis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Ingrowing nail
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Lividity
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Papule
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 erythematous
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 papular
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Skin lesion
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
3.2%
6/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.8%
9/187 • 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
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.2%
6/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
3.8%
7/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.2%
6/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
4.3%
8/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 twitching
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 tightness
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Arthritis
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Bone cyst
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Chondritis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Foot deformity
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Hypermobility syndrome
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 contracture
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Muscular weakness
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Pubic pain
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Rhabdomyolysis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Temporomandibular joint syndrome
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
3.8%
7/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
6.4%
12/187 • 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
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.2%
4/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 D deficiency
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 A deficiency
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 E deficiency
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Limb injury
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Alcohol poisoning
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Animal bite
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Ankle fracture
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 sting
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Iliotibial band syndrome
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 dislocation
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 injury
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Rib fracture
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Road traffic accident
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Splinter
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 irritation
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Thermal burn
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Traumatic haematoma
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Insomnia
|
3.8%
7/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Depression
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Nightmare
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Psychiatric disorders
Sleep disorder
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Breast tenderness
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Endometriosis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Haemorrhagic ovarian cyst
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Oligomenorrhoea
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Uterine spasm
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Vaginal haemorrhage
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
Vulvovaginal pain
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Vulvovaginal pruritus
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.6%
3/187 • 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 discomfort
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 positional
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Vision blurred
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Eye pruritus
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Blindness transient
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Eye irritation
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Eye pain
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Eye swelling
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Periorbital oedema
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Eye disorders
Photopsia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Proteinuria
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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 ureteric
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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 colic
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Flushing
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Orthostatic hypotension
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Vascular disorders
Venous thrombosis limb
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Tachycardia
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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
|
2.7%
5/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
1.1%
2/187 • 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
Talipes
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Increased tendency to bruise
|
1.1%
2/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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
Leukopenia
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Immune system disorders
Food allergy
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Endocrine disorders
Cushingoid
|
0.54%
1/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/187 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
|
Endocrine disorders
Early menarche
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.00%
0/186 • up to Week 28
Participants were analyzed as per actual treatment received. Other adverse events includes only non-serious AEs.
|
0.53%
1/187 • 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