Trial Outcomes & Findings for Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation (NCT NCT01614470)
NCT ID: NCT01614470
Last Updated: 2014-10-29
Results Overview
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Part 1: Baseline (pre-dose Day 1), Week 8
Results posted on
2014-10-29
Participant Flow
Participant milestones
| Measure |
Part 1: Ivacaftor First, Then Placebo
Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
|
Part 1: Placebo First, Then Ivacaftor
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
|
Part 2: Ivacaftor
Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
|
|---|---|---|---|
|
Part 1: Treatment Period 1 (8 Weeks)
STARTED
|
20
|
19
|
0
|
|
Part 1: Treatment Period 1 (8 Weeks)
COMPLETED
|
18
|
18
|
0
|
|
Part 1: Treatment Period 1 (8 Weeks)
NOT COMPLETED
|
2
|
1
|
0
|
|
Part 1: Washout Period (4 to 8 Weeks)
STARTED
|
18
|
18
|
0
|
|
Part 1: Washout Period (4 to 8 Weeks)
COMPLETED
|
18
|
18
|
0
|
|
Part 1: Washout Period (4 to 8 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part 1: Treatment Period 2 (8 Weeks)
STARTED
|
18
|
18
|
0
|
|
Part 1: Treatment Period 2 (8 Weeks)
COMPLETED
|
18
|
18
|
0
|
|
Part 1: Treatment Period 2 (8 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part 2: Open-label Period (16 Weeks)
STARTED
|
0
|
0
|
36
|
|
Part 2: Open-label Period (16 Weeks)
COMPLETED
|
0
|
0
|
36
|
|
Part 2: Open-label Period (16 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Ivacaftor First, Then Placebo
Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
|
Part 1: Placebo First, Then Ivacaftor
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
|
Part 2: Ivacaftor
Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
|
|---|---|---|---|
|
Part 1: Treatment Period 1 (8 Weeks)
Lost to Follow-up
|
1
|
0
|
0
|
|
Part 1: Treatment Period 1 (8 Weeks)
Need to extend washout period
|
1
|
1
|
0
|
Baseline Characteristics
Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation
Baseline characteristics by cohort
| Measure |
Part 1: Ivacaftor First, Then Placebo
n=20 Participants
Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
|
Part 1: Placebo First, Then Ivacaftor
n=19 Participants
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.8 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
21.7 years
STANDARD_DEVIATION 12.92 • n=7 Participants
|
22.8 years
STANDARD_DEVIATION 12.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Part 1: Baseline (pre-dose Day 1), Week 8Population: FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, "n" signifies those subjects who were evaluable for this measure at given time point for each group, respectively.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=38 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
n=37 Participants
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 1: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 8
Baseline (n=38, 37)
|
76.3659 percent predicted of FEV1
Standard Deviation 20.33450
|
79.3361 percent predicted of FEV1
Standard Deviation 20.83991
|
|
Part 1: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 8
Change Through Week 8 (n=37, 37)
|
8.1308 percent predicted of FEV1
Standard Deviation 9.94676
|
-5.8738 percent predicted of FEV1
Standard Deviation 7.23722
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week 12), Week 36Population: FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Absolute change in percent predicted FEV1 over 24 weeks of ivacaftor treatment (from Week 12 \[Part 1: Treatment Period 2\] through Week 36 \[Part 2\]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2, as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=18 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through 24 Weeks of Treatment (Week 36 Visit)
Baseline
|
74.8375 percent predicted of FEV1
Standard Deviation 19.36754
|
—
|
|
Part 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through 24 Weeks of Treatment (Week 36 Visit)
Change Through Week 36
|
13.5307 percent predicted of FEV1
Standard Deviation 10.18174
|
—
|
SECONDARY outcome
Timeframe: Part 1: Baseline (pre-dose Day 1), Week 8Population: FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, "n" signifies those subjects who were evaluable for this measure at given time point for each group, respectively.
BMI was defined as weight in kilogram (kg) divided by height in meters\^2 (m\^2). Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=38 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
n=37 Participants
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 1: Change From Baseline in Body Mass Index (BMI) at Week 8
Baseline (n=38, 37)
|
22.241 kg/m^2
Standard Deviation 5.1880
|
22.527 kg/m^2
Standard Deviation 4.9956
|
|
Part 1: Change From Baseline in Body Mass Index (BMI) at Week 8
Change at Week 8 (n=37, 37)
|
0.748 kg/m^2
Standard Deviation 0.5793
|
0.043 kg/m^2
Standard Deviation 0.6980
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Week 12), Week 36Population: FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.
BMI was defined as weight in kg divided by height in m\^2. Change in BMI over 24 weeks of ivacaftor treatment (from Week 12 \[Part 1: Treatment Period 2\] through Week 36 \[Part 2\]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=18 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 2: Change From Baseline in Body Mass Index (BMI) at 24 Weeks of Treatment (Week 36 Visit)
Baseline
|
22.222 kg/m^2
Standard Deviation 6.2919
|
—
|
|
Part 2: Change From Baseline in Body Mass Index (BMI) at 24 Weeks of Treatment (Week 36 Visit)
Change at Week 36
|
1.263 kg/m^2
Standard Deviation 0.7588
|
—
|
SECONDARY outcome
Timeframe: Part 1: Baseline (pre-dose Day 1), Week 8Population: FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, "n" signifies those subjects who were evaluable for this measure at given time point for each group, respectively.
Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (\>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=38 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
n=37 Participants
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 1: Change From Baseline in Sweat Chloride Through Week 8
Baseline (n=38, 37)
|
93.37 millimole per liter (mmol/L)
Standard Deviation 18.099
|
94.23 millimole per liter (mmol/L)
Standard Deviation 20.581
|
|
Part 1: Change From Baseline in Sweat Chloride Through Week 8
Change Through Week 8 (n=36, 36)
|
-55.82 millimole per liter (mmol/L)
Standard Deviation 24.890
|
-5.63 millimole per liter (mmol/L)
Standard Deviation 9.833
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Week 12), Week 36Population: FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure. Here "n" signifies those subjects who were evaluable for this measure at given time point.
Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (\>=) 15 microliter was required for determination of sweat chloride. Change in sweat chloride over 24 weeks of ivacaftor treatment (from Week 12 \[Part 1: Treatment Period 2\] through Week 36 \[Part 2\]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=18 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 2: Change From Baseline in Sweat Chloride Through 24 Weeks of Treatment (Week 36 Visit)
Change Through Week 36 (n=17)
|
-59.24 mmol/L
Standard Deviation 32.566
|
—
|
|
Part 2: Change From Baseline in Sweat Chloride Through 24 Weeks of Treatment (Week 36 Visit)
Baseline (n=18)
|
92.03 mmol/L
Standard Deviation 11.468
|
—
|
SECONDARY outcome
Timeframe: Part 1: Baseline (pre-dose Day 1), Week 8Population: FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, "n" signifies those subjects who were evaluable for this measure at given time point for each group, respectively.
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=38 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
n=37 Participants
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 1: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 8
Baseline (n=38, 37)
|
70.61 units on a scale
Standard Deviation 17.409
|
74.55 units on a scale
Standard Deviation 20.616
|
|
Part 1: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 8
Change Through Week 8 (n=37, 37)
|
12.31 units on a scale
Standard Deviation 16.891
|
-2.33 units on a scale
Standard Deviation 20.648
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Week 12), Week 36Population: FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Change in CFQ-R respiratory domain score over 24 weeks of ivacaftor treatment (from Week 12 \[Part 1: Treatment Period 2\] through Week 36 \[Part 2\]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=18 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 2: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through 24 Weeks of Treatment (Week 36 Visit)
Baseline
|
71.30 units on a scale
Standard Deviation 19.526
|
—
|
|
Part 2: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through 24 Weeks of Treatment (Week 36 Visit)
Change Through Week 36
|
11.42 units on a scale
Standard Deviation 13.604
|
—
|
SECONDARY outcome
Timeframe: Part 1: From signing of informed consent up to Week 20Population: Safety Set for Part 1 included all subjects who received at least 1 dose of study drug (ivacaftor or placebo).
AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=38 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
n=37 Participants
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
28 participants
|
31 participants
|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Part 2: Week 20 up to Week 40Population: Safety Set for Part 2 included all subjects who received at least 1 dose of study drug (ivacaftor).
AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.
Outcome measures
| Measure |
Part 1: Ivacaftor
n=36 Participants
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
|---|---|---|
|
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
30 participants
|
—
|
|
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
3 participants
|
—
|
Adverse Events
Part 1: Ivacaftor
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Part 1: Placebo
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Part 2: Ivacaftor
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Ivacaftor
n=38 participants at risk
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
n=37 participants at risk
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 2: Ivacaftor
n=36 participants at risk
Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Distal Ileal Obstruction Syndrome
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Appendiceal Mucocoele
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Cyst
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
5.3%
2/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
16.2%
6/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.6%
2/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Nervous system disorders
Convulsion
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Nervous system disorders
Dizziness
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
Other adverse events
| Measure |
Part 1: Ivacaftor
n=38 participants at risk
Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 1: Placebo
n=37 participants at risk
Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
|
Part 2: Ivacaftor
n=36 participants at risk
Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
|
|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
18.4%
7/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
16.2%
6/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
11.1%
4/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Rhinitis
|
7.9%
3/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Influenza
|
5.3%
2/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Conjunctivitis infective
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Respiratory tract infection viral
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Sinusitis
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.6%
2/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
8.3%
3/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Bronchitis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Impetigo
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
6/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
18.9%
7/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
13.9%
5/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
7.9%
3/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
8.1%
3/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.6%
2/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Lung hyperinflation
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
8.1%
3/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
8.3%
3/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
8.1%
3/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.6%
2/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
8.3%
3/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.6%
2/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.6%
2/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord inflammation
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Pyrexia
|
7.9%
3/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.6%
2/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Fatigue
|
5.3%
2/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Chest pain
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Exercise tolerance decreased
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Malaise
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Medical device site reaction
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Oedema peripheral
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Infusion site thrombosis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Injection site pain
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Constipation
|
5.3%
2/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.6%
2/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
10.8%
4/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
8.3%
3/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.6%
2/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Distal ileal obstruction syndrome
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
10.8%
4/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Toothache
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Nervous system disorders
Headache
|
7.9%
3/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
13.5%
5/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
11.1%
4/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Nervous system disorders
Dysgeusia
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Nervous system disorders
Sinus headache
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Nervous system disorders
Lethargy
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
Blood creatinine increased
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
C-reactive protein increased
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
Neutrophil count increased
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
Respiratory rate increased
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
White blood cell count increased
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Investigations
Weight decreased
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
5.4%
2/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
2/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Endocrine disorders
Thyroid disorder
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Vascular disorders
Orthostatic hypotension
|
2.6%
1/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Vascular disorders
Hypertension
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.7%
1/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/38 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
0.00%
0/37 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
2.8%
1/36 • Part 1: From signing of informed consent up to Week 20; Part 2: Week 20 up to Week 40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
- Publication restrictions are in place
Restriction type: OTHER