Trial Outcomes & Findings for Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response (NCT NCT01128595)
NCT ID: NCT01128595
Last Updated: 2017-01-18
Results Overview
Forced expiratory volume in one second (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen (administered by inhalation) 1 hr after dosing on Day 21. Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Day 21 of each treatment period (up to Study Day 197)
Results posted on
2017-01-18
Participant Flow
Participants meeting all of the inclusion criteria and none of the exclusion criteria during the Screening Visit, conducted 14-42 days prior to the first dose of study medication, entered a 14-day Run-in Period. Participants were then randomized to 4 Treatment Periods, each lasting 21 days and separated by a nominal washout period of 21-35 days.
Participant milestones
| Measure |
Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg
Participants received Vilanterol (VI) 25 micrograms (µg), placebo, fluticasone furoate (FF) 100 µg, and FF/VI 100/25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
|
Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg
Participants received FF/VI 100/25 µg, FF 100 µg, placebo, and VI 25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
|
Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg
Participants received placebo, FF/VI 100/25 µg, VI 25 µg, and FF 100 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
|
Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo
Participants received FF 100 µg, VI 25 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
|
|---|---|---|---|---|
|
Treatment Period 2
STARTED
|
7
|
6
|
7
|
7
|
|
Treatment Period 2
COMPLETED
|
7
|
6
|
7
|
7
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
7
|
6
|
7
|
7
|
|
Treatment Period 1
STARTED
|
7
|
6
|
7
|
7
|
|
Treatment Period 1
COMPLETED
|
7
|
6
|
7
|
7
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
7
|
6
|
7
|
7
|
|
Washout Period 1
COMPLETED
|
7
|
6
|
7
|
7
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2
COMPLETED
|
7
|
6
|
7
|
7
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
7
|
6
|
7
|
7
|
|
Treatment Period 3
COMPLETED
|
7
|
5
|
7
|
7
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Washout Period 3
STARTED
|
7
|
5
|
7
|
7
|
|
Washout Period 3
COMPLETED
|
7
|
5
|
7
|
7
|
|
Washout Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
7
|
5
|
7
|
7
|
|
Treatment Period 4
COMPLETED
|
7
|
5
|
7
|
7
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg
Participants received Vilanterol (VI) 25 micrograms (µg), placebo, fluticasone furoate (FF) 100 µg, and FF/VI 100/25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
|
Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg
Participants received FF/VI 100/25 µg, FF 100 µg, placebo, and VI 25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
|
Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg
Participants received placebo, FF/VI 100/25 µg, VI 25 µg, and FF 100 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
|
Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo
Participants received FF 100 µg, VI 25 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
|
|---|---|---|---|---|
|
Treatment Period 3
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response
Baseline characteristics by cohort
| Measure |
Placebo, FF/VI 100/25 µg OD, FF 100 µg OD, VI 25 µg
n=27 Participants
All participants received one of the following four treatments in one of four treatment periods once daily (OD) from the Dry Powder Inhaler (DPI) for 21 days: Placebo; Fluticasone Furoate /Vilanterol (FF/VI) 100/25 microgram (µg) dry inhalation powder; Fluticasone Furoate (FF) 100 µg dry inhalation powder; and Vilanterol (VI) 25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the four following sequences: (1) VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg; (2) FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg; (3) Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg; (4) FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo. The four treatment periods were separated by a washout period of 21 to 35 days.
|
|---|---|
|
Age, Continuous
|
30.8 Years
STANDARD_DEVIATION 7.46 • n=99 Participants
|
|
Gender
Female
|
8 Participants
n=99 Participants
|
|
Gender
Male
|
19 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European Heritage
|
25 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
East Asian Heritage
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 21 of each treatment period (up to Study Day 197)Population: Efficacy Population: all participants who received at least one dose of study medication, had a post-dose FEV1 assessment, and who were not major protocol violators. Only those participants available at the specified time points were analyzed.
Forced expiratory volume in one second (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen (administered by inhalation) 1 hr after dosing on Day 21. Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
Outcome measures
| Measure |
Placebo
n=20 Participants
|
FF/VI 100/25 µg OD
n=26 Participants
Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
FF 100 µg OD
n=27 Participants
Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
VI 25 µg OD
n=22 Participants
Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
|---|---|---|---|---|
|
Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
|
-0.731 Liters
Interval -0.878 to -0.584
|
-0.216 Liters
Interval -0.343 to -0.088
|
-0.188 Liters
Interval -0.315 to -0.061
|
-0.536 Liters
Interval -0.676 to -0.396
|
PRIMARY outcome
Timeframe: Day 21 of each treatment period (up to Study Day 197)Population: Efficacy Population. Only those participants available at the specified time points were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 21. LAR FEV1 was measured 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 21. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
Outcome measures
| Measure |
Placebo
n=20 Participants
|
FF/VI 100/25 µg OD
n=26 Participants
Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
FF 100 µg OD
n=27 Participants
Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
VI 25 µg OD
n=22 Participants
Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
|---|---|---|---|---|
|
LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
|
-0.466 Liters
Interval -0.589 to -0.343
|
0.018 Liters
Interval -0.089 to 0.125
|
0.018 Liters
Interval -0.089 to 0.124
|
-0.298 Liters
Interval -0.415 to -0.181
|
PRIMARY outcome
Timeframe: Day 21 of each treatment period (up to Study Day 197)Population: Efficacy Population. Only those participants available at the specified time points were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
Outcome measures
| Measure |
Placebo
n=22 Participants
|
FF/VI 100/25 µg OD
n=27 Participants
Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
FF 100 µg OD
n=27 Participants
Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
VI 25 µg OD
n=22 Participants
Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
|---|---|---|---|---|
|
Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
|
-1.091 Liters
Interval -1.344 to -0.837
|
-0.614 Liters
Interval -0.858 to -0.37
|
-0.826 Liters
Interval -1.07 to -0.581
|
-0.955 Liters
Interval -1.209 to -0.702
|
PRIMARY outcome
Timeframe: Day 21 of each treatment period (up to Study Day 197)Population: Efficacy Population. Only those participants available at the specified time points were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. The EAR FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Least squares means were obtained by adjusting for period and participant and period Baselines. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.
Outcome measures
| Measure |
Placebo
n=22 Participants
|
FF/VI 100/25 µg OD
n=27 Participants
Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
FF 100 µg OD
n=27 Participants
Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
VI 25 µg OD
n=22 Participants
Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
|---|---|---|---|---|
|
EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
|
-0.560 Liters
Interval -0.745 to -0.374
|
-0.297 Liters
Interval -0.476 to -0.118
|
-0.386 Liters
Interval -0.565 to -0.207
|
-0.533 Liters
Interval -0.718 to -0.348
|
SECONDARY outcome
Timeframe: Day 21 of each treatment period (up to Study Day 197)Population: Efficacy Population. Only those participants available at the specified time points were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Maximum percent change was calculated as the minimum FEV1 minus the saline FEV1 value divided by the saline FEV1 multiplied by 100. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline FEV1 value.
Outcome measures
| Measure |
Placebo
n=22 Participants
|
FF/VI 100/25 µg OD
n=27 Participants
Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
FF 100 µg OD
n=27 Participants
Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
VI 25 µg OD
n=22 Participants
Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
|---|---|---|---|---|
|
Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
|
-26.13 percent change
Interval -58.9 to -5.4
|
-10.43 percent change
Interval -58.9 to -2.1
|
-16.14 percent change
Interval -64.9 to -4.0
|
-18.35 percent change
Interval -59.3 to -4.4
|
SECONDARY outcome
Timeframe: Day 22 of each treatment period (up to Study Day 198)Population: Efficacy Population. Only those participants available at the specified time points were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a \>=20% fall in FEV1 from the saline value was achieved. After inhalation of saline, 3 measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.
Outcome measures
| Measure |
Placebo
n=23 Participants
|
FF/VI 100/25 µg OD
n=27 Participants
Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
FF 100 µg OD
n=25 Participants
Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
VI 25 µg OD
n=24 Participants
Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
|---|---|---|---|---|
|
Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period
|
1.046 milligrams per milliliter
Standard Deviation 3.3191
|
2.500 milligrams per milliliter
Standard Deviation 3.7363
|
2.492 milligrams per milliliter
Standard Deviation 5.3371
|
0.387 milligrams per milliliter
Standard Deviation 0.5311
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
FF/VI 100/25 µg OD
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
FF 100 µg OD
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
VI 25 µg OD
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
FF/VI 100/25 µg OD
n=27 participants at risk
Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
FF 100 µg OD
n=27 participants at risk
Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
VI 25 µg OD
n=26 participants at risk
Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
40.7%
11/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
55.6%
15/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
55.6%
15/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
50.0%
13/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
2/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
11.1%
3/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
7.4%
2/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
19.2%
5/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
7.4%
2/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Oral candidiasis
|
7.4%
2/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Eczema infected
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.4%
2/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
11.1%
3/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
7.4%
2/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
11.5%
3/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
7.7%
2/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Eye penetration
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
7.4%
2/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
11.1%
3/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.4%
2/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.8%
1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
3.7%
1/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/27 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).
SAEs and non-serious AEs were reported for members of the All Participants Population, comprised of all participants who received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER