Trial Outcomes & Findings for Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor (NCT NCT02544451)
NCT ID: NCT02544451
Last Updated: 2021-05-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
246 participants
Primary outcome timeframe
Day 1 up to Week 100
Results posted on
2021-05-24
Participant Flow
This study consists of 2 Treatment Periods: Treatment Period 1 and Treatment Period 2. Treatment Period 1 had Treatment Cohorts and an Observational Cohort.
Participants from Parent Studies 109 (NCT02514473) and 011B (NCT01897233) were enrolled in this study. A total of 240 participants were enrolled in Treatment Period 1 Treatment Cohorts, out of which 1 participant was enrolled but never dosed. Participants enrolled in the Observational and Treatment Period 2 Cohorts were followed for safety endpoint only, no efficacy data were collected.
Participant milestones
| Measure |
Treatment Period 1: LUM/IVA to LUM/IVA
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
Treatment Period 1: PBO to LUM/IVA
Participants received placebo (PBO) in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
Treatment Period 1: Observational Cohort
Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.
|
Treatment Period 2: LUM/IVA
Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.
|
|---|---|---|---|---|
|
Treatment Period 1 (96 Weeks)
STARTED
|
143
|
96
|
6
|
0
|
|
Treatment Period 1 (96 Weeks)
COMPLETED
|
129
|
84
|
5
|
0
|
|
Treatment Period 1 (96 Weeks)
NOT COMPLETED
|
14
|
12
|
1
|
0
|
|
Treatment Period 2 (168 Weeks)
STARTED
|
0
|
0
|
0
|
10
|
|
Treatment Period 2 (168 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (168 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
10
|
Reasons for withdrawal
| Measure |
Treatment Period 1: LUM/IVA to LUM/IVA
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
Treatment Period 1: PBO to LUM/IVA
Participants received placebo (PBO) in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
Treatment Period 1: Observational Cohort
Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.
|
Treatment Period 2: LUM/IVA
Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.
|
|---|---|---|---|---|
|
Treatment Period 1 (96 Weeks)
Adverse Event
|
1
|
6
|
0
|
0
|
|
Treatment Period 1 (96 Weeks)
Withdrawal of consent (not due to AE)
|
3
|
2
|
1
|
0
|
|
Treatment Period 1 (96 Weeks)
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Treatment Period 1 (96 Weeks)
Physician Decision
|
4
|
0
|
0
|
0
|
|
Treatment Period 1 (96 Weeks)
Other
|
4
|
4
|
0
|
0
|
|
Treatment Period 2 (168 Weeks)
Commercial drug is available for subject
|
0
|
0
|
0
|
10
|
Baseline Characteristics
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Baseline characteristics by cohort
| Measure |
LUM/IVA to LUM/IVA
n=143 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=96 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
Observational Cohort
n=6 Participants
Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Less than 9 Years
|
58 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Age, Customized
Greater than or equal to 9 years
|
85 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 100Population: Safety set included all participants who received at least 1 dose of study drug in Treatment Period 1.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=143 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=96 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Treatment Period 1 (Treatment Cohorts): Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with any AEs
|
142 participants
|
94 participants
|
|
Treatment Period 1 (Treatment Cohorts): Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
43 participants
|
29 participants
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: LCI set includes all participants enrolled and dosed in either parent study 109 or 011B LCI sub-study. Analysis period includes both parent study and current study.
LCI 2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=133 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Lung Clearance Index (LCI) 2.5
|
-0.85 lung clearance index
Interval -1.25 to -0.45
|
-0.86 lung clearance index
Interval -1.33 to -0.38
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: Full Analysis Set (FAS) includes all participants enrolled and dosed in either parent study. Analysis period includes both parent study and current study.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Sweat Chloride
|
-22.9 millimole per liter (mmol/L)
Interval -25.5 to -20.3
|
-22.8 millimole per liter (mmol/L)
Interval -26.3 to -19.3
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
BMI was defined as weight in kilograms divided by height in square meter (m\^2).
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Body Mass Index (BMI)
|
1.78 kg/m^2
Interval 1.56 to 1.99
|
2.04 kg/m^2
Interval 1.77 to 2.31
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
|
7.4 units on a scale
Interval 4.8 to 10.0
|
6.6 units on a scale
Interval 3.1 to 10.0
|
SECONDARY outcome
Timeframe: Day 1 up to Week 100Population: All participants included in the observational cohort.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=6 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Observational Cohort: Safety as Assessed by Serious Adverse Events (SAEs)
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: LCI set.
LCI 5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=133 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in LCI 5.0
|
-0.21 lung clearance index
Interval -0.36 to -0.06
|
-0.31 lung clearance index
Interval -0.49 to -0.13
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
3.1 percent predicted of FEV1
Interval 1.0 to 5.1
|
0.0 percent predicted of FEV1
Interval -2.7 to 2.7
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Relative Change in ppFEV1
|
4.9 percent change
Interval 2.2 to 7.5
|
0.5 percent change
Interval -2.9 to 4.0
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
BMI was defined as weight in kilograms divided by height in m\^2. z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in BMI-for-age Z-score
|
0.17 z-score
Interval 0.08 to 0.26
|
0.31 z-score
Interval 0.19 to 0.42
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Weight
|
10.3 kg
Interval 9.6 to 11.0
|
11.0 kg
Interval 10.1 to 11.8
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Weight-for-age Z-score
|
0.12 z-score
Interval 0.04 to 0.2
|
0.24 z-score
Interval 0.14 to 0.34
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Height
|
13.4 centimeter (cm)
Interval 12.9 to 14.0
|
13.5 centimeter (cm)
Interval 12.8 to 14.1
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Height-for-age Z-score
|
-0.01 z-score
Interval -0.08 to 0.07
|
0.02 z-score
Interval -0.07 to 0.11
|
SECONDARY outcome
Timeframe: From Parent Study Baseline at Week 96Population: FAS.
The TSQM measures participants' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed in the total domain score, which ranges from 0 to 100, where higher scores indicate greater satisfaction.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=161 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=101 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Absolute Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Domain Score
|
5.1 units on a scale
Interval 1.7 to 8.4
|
3.9 units on a scale
Interval -0.6 to 8.5
|
SECONDARY outcome
Timeframe: From Parent Study Baseline through Week 96Population: Analysis included all participants dosed in parent study 109. LUM/IVA to LUM/IVA analysis period includes both parent study and current study. PBO to LUM/IVA analysis period includes the current study only.
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=103 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=96 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Time-to-first Pulmonary Exacerbation
|
720.00 days
Interval 278.0 to
Upper limit of inter-quartile range could not be estimated because less than 75% of participants had events.
|
NA days
Interval 513.0 to
Median and upper limit of inter-quartile range could not be estimated because less than 50% of participants had events.
|
SECONDARY outcome
Timeframe: From Parent Study Baseline through Week 96Population: Analysis included all participants dosed in parent study 109. LUM/IVA to LUM/IVA analysis period includes both parent study and current study. PBO to LUM/IVA analysis period includes the current study only.
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=103 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=96 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Percentage of Participants Having At Least 1 Pulmonary Exacerbation Event
|
49.5 percentage of participants
|
32.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Parent Study Baseline through Week 96Population: Analysis included all participants dosed in parent study 109. LUM/IVA to LUM/IVA analysis period includes both parent study and current study. PBO to LUM/IVA analysis period includes the current study only.
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=103 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
n=96 Participants
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Number of Pulmonary Exacerbation Events Per Patient-year
|
0.45 events per patient-year
Interval 0.33 to 0.61
|
0.30 events per patient-year
Interval 0.21 to 0.43
|
SECONDARY outcome
Timeframe: Day 15 after first dose of LUM/IVA through Week 96Population: As pre-specified in the SAP, this analysis was conducted in the LUM/IVA Overall group because of sample size. Analysis period is 15 days after first dose of LUM/IVA in parent study or current study (if assigned to placebo in study 109) through the end of current study.
Rate of change analysis evaluates the change in LCI 2.5 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=229 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Rate of Change in LCI 2.5
|
-0.01 slope
Interval -0.12 to 0.09
|
—
|
SECONDARY outcome
Timeframe: Day 15 after first dose of LUM/IVA through Week 96Population: As pre-specified in the SAP, this analysis was conducted in the LUM/IVA Overall group because of sample size. Analysis period is 15 days after first dose of LUM/IVA in parent study or current study (if assigned to placebo in study 109) through the end of current study.
Rate of change analysis evaluates the change in LCI 5.0 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=229 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Rate of Change in LCI 5.0
|
0.00 slope
Interval -0.04 to 0.04
|
—
|
SECONDARY outcome
Timeframe: Day 15 after first dose of LUM/IVA through Week 96Population: As pre-specified in the SAP, this analysis was conducted in the LUM/IVA Overall group because of sample size. Analysis period is 15 days after first dose of LUM/IVA in parent study or current study (if assigned to placebo in study 109) through the end of current study.
Rate of change analysis evaluates the change in ppFEV1 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=257 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Rate of Change in ppFEV1
|
0.58 slope
Interval 0.02 to 1.14
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Week 168Population: Safety set included all participants who received at least 1 dose of study drug in Treatment Period 2.
Outcome measures
| Measure |
LUM/IVA to LUM/IVA
n=10 Participants
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
PBO to LUM/IVA
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
|---|---|---|
|
Treatment Period 2: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with any AEs
|
9 participants
|
—
|
|
Treatment Period 2: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 participants
|
—
|
Adverse Events
Treatment Period 1: LUM/IVA to LUM/IVA
Serious events: 43 serious events
Other events: 141 other events
Deaths: 0 deaths
Treatment Period 1: PBO to LUM/IVA
Serious events: 29 serious events
Other events: 93 other events
Deaths: 0 deaths
Treatment Period 1: Observational Cohort
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Period 2: LUM/IVA
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Period 1: LUM/IVA to LUM/IVA
n=143 participants at risk
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
Treatment Period 1: PBO to LUM/IVA
n=96 participants at risk
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
Treatment Period 1: Observational Cohort
n=6 participants at risk
Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.
|
Treatment Period 2: LUM/IVA
n=10 participants at risk
Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
23.8%
34/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
15.6%
15/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
16.7%
1/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
1.4%
2/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Pneumonia
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Atypical mycobacterial lower respiratory tract infection
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Pulmonary function test decreased
|
1.4%
2/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
2.1%
2/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
2.1%
2/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
2.1%
2/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Pseudomonas test positive
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Atypical mycobacterium test positive
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Oxygen saturation decreased
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
4/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis hepatic disease
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis lung
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
General disorders
Pyrexia
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/6 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
Other adverse events
| Measure |
Treatment Period 1: LUM/IVA to LUM/IVA
n=143 participants at risk
Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.
|
Treatment Period 1: PBO to LUM/IVA
n=96 participants at risk
Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.
|
Treatment Period 1: Observational Cohort
n=6 participants at risk
Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.
|
Treatment Period 2: LUM/IVA
n=10 participants at risk
Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
41.3%
59/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
35.4%
34/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
40.0%
4/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.2%
36/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
13.5%
13/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Nasopharyngitis
|
14.7%
21/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
16.7%
16/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
30.0%
3/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.6%
8/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.7%
21/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
14.6%
14/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Sinusitis
|
11.9%
17/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
8.3%
8/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Otitis media
|
9.1%
13/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
8.3%
8/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Pharyngitis streptococcal
|
8.4%
12/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
6.2%
6/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Bacterial disease carrier
|
7.7%
11/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
6.2%
6/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
20.0%
2/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Influenza
|
7.7%
11/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
6.2%
6/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Ear infection
|
6.3%
9/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
7.3%
7/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Rhinitis
|
6.3%
9/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
7.3%
7/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
60.0%
6/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
5.6%
8/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Bronchitis
|
4.9%
7/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
7.3%
7/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
20.0%
2/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Pharyngitis
|
3.5%
5/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
7.3%
7/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
63.6%
91/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
66.7%
64/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
20.0%
2/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
23.8%
34/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
21.9%
21/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
22.4%
32/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
18.8%
18/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.8%
24/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
13.5%
13/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.3%
19/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
15.6%
15/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
12.6%
18/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
7.3%
7/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.4%
12/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
4.2%
4/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
6.3%
9/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
3.1%
3/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
8/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
4.2%
4/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
4.9%
7/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
7.3%
7/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.5%
5/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
5.2%
5/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
4/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
6.2%
6/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Vomiting
|
21.0%
30/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
15.6%
15/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.4%
22/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
20.8%
20/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.9%
17/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
19.8%
19/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.2%
16/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
8.3%
8/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
13/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
11.5%
11/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
11/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
11.5%
11/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Flatulence
|
2.8%
4/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
6.2%
6/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Bacterial test positive
|
21.0%
30/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
16.7%
16/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
22/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
21.9%
21/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Aspartate aminotransferase increased
|
11.9%
17/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
13.5%
13/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Pseudomonas test positive
|
7.0%
10/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
3.1%
3/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Pulmonary function test decreased
|
5.6%
8/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
11.5%
11/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.2%
6/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
6.2%
6/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Forced expiratory volume decreased
|
4.2%
6/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
13.5%
13/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
International normalised ratio increased
|
2.8%
4/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
6.2%
6/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Prothrombin time prolonged
|
2.1%
3/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
6.2%
6/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Weight decreased
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
5.2%
5/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
General disorders
Pyrexia
|
31.5%
45/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
28.1%
27/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
General disorders
Fatigue
|
7.0%
10/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
11.5%
11/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
General disorders
Chest pain
|
1.4%
2/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
5.2%
5/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Nervous system disorders
Headache
|
20.3%
29/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
27.1%
26/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Nervous system disorders
Dizziness
|
4.2%
6/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
5.2%
5/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Ear and labyrinth disorders
Ear pain
|
8.4%
12/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
4.2%
4/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
10/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.4%
10/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Immune system disorders
Seasonal allergy
|
5.6%
8/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
5.2%
5/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
5/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
5.2%
5/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
3/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
6.2%
6/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.8%
4/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
2.1%
2/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Investigations
Pulmonary imaging procedure abnormal
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.5%
5/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
2.1%
2/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
20.0%
2/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
2.8%
4/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
2.1%
2/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
1.4%
2/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.8%
4/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
4.2%
4/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.70%
1/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Gastroenteritis
|
4.9%
7/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
4.2%
4/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Oral fungal infection
|
1.4%
2/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
0.00%
0/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
2.1%
3/143 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
1.0%
1/96 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
—
0/0 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
10.0%
1/10 • Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER