Trial Outcomes & Findings for A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years With Hypertension (NCT NCT02791438)
NCT ID: NCT02791438
Last Updated: 2020-02-07
Results Overview
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
27 participants
Primary outcome timeframe
Up to Week 54
Results posted on
2020-02-07
Participant Flow
The study was conducted at 17 investigative sites in Japan from 18 August 2016 to 04 June 2019.
Following a placebo run-in period, pediatric patients with hypertension received azilsartan at starting doses of 2.5 mg for patients \< 50 kilograms (kg) and 5 mg for patients ≥ 50 kg.
Participant milestones
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Run-In Period
STARTED
|
22
|
5
|
|
Run-In Period
COMPLETED
|
22
|
5
|
|
Run-In Period
NOT COMPLETED
|
0
|
0
|
|
Treatment Period
STARTED
|
22
|
5
|
|
Treatment Period
COMPLETED
|
19
|
4
|
|
Treatment Period
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
0
|
|
Treatment Period
Withdrawal by Subject
|
0
|
1
|
|
Treatment Period
Withdrawal by Parent/Guardian
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.0 years
STANDARD_DEVIATION 2.54 • n=22 Participants
|
12.8 years
STANDARD_DEVIATION 2.49 • n=5 Participants
|
9.7 years
STANDARD_DEVIATION 2.91 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=22 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=22 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
22 Participants
n=22 Participants
|
5 Participants
n=5 Participants
|
27 Participants
n=27 Participants
|
|
Height
|
128.4 cm
STANDARD_DEVIATION 10.92 • n=22 Participants
|
160.4 cm
STANDARD_DEVIATION 16.30 • n=5 Participants
|
134.3 cm
STANDARD_DEVIATION 17.26 • n=27 Participants
|
|
Weight
|
31.94 kg
STANDARD_DEVIATION 8.306 • n=22 Participants
|
63.78 kg
STANDARD_DEVIATION 10.139 • n=5 Participants
|
37.83 kg
STANDARD_DEVIATION 15.180 • n=27 Participants
|
|
Body Mass Index (BMI)
|
19.29 kg/m^2
STANDARD_DEVIATION 4.216 • n=22 Participants
|
24.86 kg/m^2
STANDARD_DEVIATION 2.726 • n=5 Participants
|
20.32 kg/m^2
STANDARD_DEVIATION 4.513 • n=27 Participants
|
|
Disease Duration
|
2.30 years
STANDARD_DEVIATION 2.152 • n=22 Participants
|
1.66 years
STANDARD_DEVIATION 2.418 • n=5 Participants
|
2.18 years
STANDARD_DEVIATION 2.168 • n=27 Participants
|
|
Office Sitting Blood Pressure (Systolic) at Week 0
|
123.2 mmHg
STANDARD_DEVIATION 12.55 • n=22 Participants
|
136.6 mmHg
STANDARD_DEVIATION 8.32 • n=5 Participants
|
125.7 mmHg
STANDARD_DEVIATION 12.89 • n=27 Participants
|
|
Office Sitting Blood Pressure (Diastolic) at Week 0
|
72.1 mmHg
STANDARD_DEVIATION 14.01 • n=22 Participants
|
71.6 mmHg
STANDARD_DEVIATION 11.87 • n=5 Participants
|
72.0 mmHg
STANDARD_DEVIATION 13.43 • n=27 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
99.571 mL/min/1.73m^2
STANDARD_DEVIATION 30.9858 • n=22 Participants
|
131.438 mL/min/1.73m^2
STANDARD_DEVIATION 26.1758 • n=5 Participants
|
105.472 mL/min/1.73m^2
STANDARD_DEVIATION 32.2493 • n=27 Participants
|
PRIMARY outcome
Timeframe: Up to Week 54Population: Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
19 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 54Population: Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Anthropometric Measurement (Weight, Height and Body Mass Index (BMI))
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 54Population: Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.
The laboratory values outside the range (Blood Urea Nitrogen (BUN) (mg/dL) \>30, Creatinine (mg/dL) \>2.0, eGFR (mL/min/1.73m\^2) \<30, Creatine Kinase (U/L) \>5×ULN) are considered markedly abnormal.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Number Of Participants With Markedly Abnormal Values of Laboratory Parameters
Creatinine (mg/dL) >2.0
|
1 Participants
|
0 Participants
|
|
Number Of Participants With Markedly Abnormal Values of Laboratory Parameters
eGFR (mL/min/1.73m^2) <30
|
1 Participants
|
0 Participants
|
|
Number Of Participants With Markedly Abnormal Values of Laboratory Parameters
Blood Urea Nitrogen (BUN) (mg/dL) >30
|
2 Participants
|
1 Participants
|
|
Number Of Participants With Markedly Abnormal Values of Laboratory Parameters
Creatine Kinase (U/L) >5×ULN
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Week 54Population: Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.
A standard 12-lead ECG was performed while the participant was at rest. Any abnormal ECG findings determined by the investigator to be clinically significant were reported as adverse events.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Number Of Participants With TEAEs Related To Resting 12-Lead Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 54Population: Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Vital signs included office standing blood pressure, office sitting pulse rate, office standing pulse rate, and home sitting blood pressure. Any abnormal vital signs findings determined by the investigator to be clinically significant were reported as adverse events.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Number Of Participants With TEAEs Related To Vital Signs (Hypotension)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), End-of-treatment (EOT) 1 (Up to Week 12), EOT 2 (Up to Week 52)Population: Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.
Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. The data of change from baseline to the End of Treatment Period I (EOT 1) and the End of the Treatment Period 2 (EOT 2) were calculated with the evaluable data within the acceptable time points (EOT1 was for up to Week 12 and EOT2 was for up to Week 52) with the largest Study Day was used. Meanwhile, change from baseline to Week 12 and 52 were calculated with the data of Week 12 and 52 respectively.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline at Week 2
|
-7.8 mmHg
Standard Deviation 11.34
|
-7.4 mmHg
Standard Deviation 5.68
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline at Week 4
|
-10.7 mmHg
Standard Deviation 12.64
|
-13.2 mmHg
Standard Deviation 11.43
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline at Week 8
|
-10.1 mmHg
Standard Deviation 10.41
|
-13.0 mmHg
Standard Deviation 10.12
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline at Week 12
|
-13.0 mmHg
Standard Deviation 10.30
|
-7.6 mmHg
Standard Deviation 10.21
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline at Week 16
|
-13.1 mmHg
Standard Deviation 12.61
|
-17.6 mmHg
Standard Deviation 6.58
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline at Week 20
|
-10.0 mmHg
Standard Deviation 11.23
|
-16.6 mmHg
Standard Deviation 11.22
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline at Week 24
|
-12.9 mmHg
Standard Deviation 13.95
|
-9.4 mmHg
Standard Deviation 11.97
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline at Week 32
|
-13.6 mmHg
Standard Deviation 16.29
|
-15.3 mmHg
Standard Deviation 10.90
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline at Week 40
|
-10.3 mmHg
Standard Deviation 14.32
|
-17.5 mmHg
Standard Deviation 12.61
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from Baseline (BL) at Week 52
|
-8.9 mmHg
Standard Deviation 12.29
|
-17.5 mmHg
Standard Deviation 8.89
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from BL at Week 54 Follow-up
|
-4.4 mmHg
Standard Deviation 12.65
|
-14.5 mmHg
Standard Deviation 2.12
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from BL at EOT 1 (Up to Week 12)
|
-13.5 mmHg
Standard Deviation 10.27
|
-7.6 mmHg
Standard Deviation 10.21
|
|
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Change from BL at EOT 2 (Up to Week 52)
|
-8.8 mmHg
Standard Deviation 11.79
|
-15.4 mmHg
Standard Deviation 9.02
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52)Population: Full analysis set included all the randomized participants. Number analyzed is the number participants with data available at the given timepoint for this outcome measure.
Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. The data of change from baseline to the End of Treatment Period I (EOT 1) and the End of the Treatment Period 2 (EOT 2) were calculated with the evaluable data within the acceptable time points (EOT1 was for up to Week 12 and EOT2 was for up to Week 52) with the largest Study Day was used. Meanwhile, change from baseline to Week 12 and 52 were calculated with the data of Week 12 and 52 respectively.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline at Week 2
|
-7.5 mmHg
Standard Deviation 11.81
|
-9.8 mmHg
Standard Deviation 5.63
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline at Week 4
|
-11.5 mmHg
Standard Deviation 14.11
|
-11.2 mmHg
Standard Deviation 10.21
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline at Week 8
|
-11.8 mmHg
Standard Deviation 13.06
|
-11.6 mmHg
Standard Deviation 11.01
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline at Week 12
|
-14.0 mmHg
Standard Deviation 13.30
|
-10.0 mmHg
Standard Deviation 10.77
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline at Week 16
|
-13.4 mmHg
Standard Deviation 13.79
|
-16.6 mmHg
Standard Deviation 8.08
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline at Week 20
|
-13.5 mmHg
Standard Deviation 13.87
|
-13.8 mmHg
Standard Deviation 9.78
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline at Week 24
|
-14.1 mmHg
Standard Deviation 16.04
|
-10.8 mmHg
Standard Deviation 7.79
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline at Week 32
|
-11.4 mmHg
Standard Deviation 15.51
|
-15.8 mmHg
Standard Deviation 15.90
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline at Week 40
|
-11.2 mmHg
Standard Deviation 16.47
|
-12.0 mmHg
Standard Deviation 11.69
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from Baseline (BL) at Week 52
|
-10.7 mmHg
Standard Deviation 14.50
|
-15.3 mmHg
Standard Deviation 10.81
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from BL at Week 54 Follow-up
|
-6.1 mmHg
Standard Deviation 9.97
|
-14.0 mmHg
Standard Deviation 5.66
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from BL at EOT I (Up to Week 12)
|
-14.8 mmHg
Standard Deviation 13.80
|
-10.0 mmHg
Standard Deviation 10.77
|
|
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Change from BL at EOT 2 (Up to Week 52)
|
-10.3 mmHg
Standard Deviation 13.97
|
-13.6 mmHg
Standard Deviation 10.06
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52)Population: Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.
Target blood pressure is defined as the normal reference range for blood pressure by age according to Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2012 (JCS 2012). The data of change from baseline to EOT 1 and EOT 2 were calculated with the evaluable data within the acceptable time points (EOT1 was for up to Week 12 and EOT2 was for up to Week 52) with the largest Study Day was used. Meanwhile, change from baseline to Week 12 and 52 were calculated with the data of Week 12 and 52 respectively. Target blood pressure were described on Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2012 (JCS 2012) (see Links on Registration Section).
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 16
|
66.7 percentage of participants
|
40.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 24
|
50.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 54 (Follow-up)
|
41.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 2
|
45.5 percentage of participants
|
40.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 4
|
45.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 8
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 12
|
73.7 percentage of participants
|
40.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 20
|
57.1 percentage of participants
|
40.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 32
|
50.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 40
|
45.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
Week 52
|
36.8 percentage of participants
|
75.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
EOT 1 (Up to Week 12)
|
68.2 percentage of participants
|
40.0 percentage of participants
|
|
Percentage Of Participants Who Achieve The Target Blood Pressure
EOT 2 (Up to Week 52)
|
36.4 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16Population: Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.
Reported data were observed plasma concentration for Azilsartan for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Observed Plasma Concentration for Azilsartan
Week 2 (Predose)
|
22.3 ug/L
Standard Deviation 18.64
|
16.8 ug/L
Standard Deviation 10.50
|
|
Observed Plasma Concentration for Azilsartan
Week 2 (Postdose)
|
206.0 ug/L
Standard Deviation 157.18
|
610.0 ug/L
Standard Deviation 12.73
|
|
Observed Plasma Concentration for Azilsartan
Week 4 (Predose)
|
31.1 ug/L
Standard Deviation 23.35
|
35.0 ug/L
Standard Deviation 19.66
|
|
Observed Plasma Concentration for Azilsartan
Week 4 (Postdose)
|
175.0 ug/L
Standard Deviation 125.87
|
64.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
|
Observed Plasma Concentration for Azilsartan
Week 8 (Predose)
|
49.2 ug/L
Standard Deviation 60.74
|
58.0 ug/L
Standard Deviation 31.65
|
|
Observed Plasma Concentration for Azilsartan
Week 8 (Postdose)
|
221.5 ug/L
Standard Deviation 177.48
|
587.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
|
Observed Plasma Concentration for Azilsartan
Week 12 (Predose)
|
48.9 ug/L
Standard Deviation 55.01
|
64.8 ug/L
Standard Deviation 37.83
|
|
Observed Plasma Concentration for Azilsartan
Week 12 (Postdose)
|
802.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
116.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
|
Observed Plasma Concentration for Azilsartan
Week 16 (Postdose)
|
743.1 ug/L
Standard Deviation 590.29
|
1675.8 ug/L
Standard Deviation 1579.32
|
SECONDARY outcome
Timeframe: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16Population: Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.
Reported data were observed plasma concentration for Azilsartan Metabolites (M-I) for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Week 8 (Predose)
|
3.1 ug/L
Standard Deviation 3.33
|
3.8 ug/L
Standard Deviation 2.36
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Week 8 (Postdose)
|
37.5 ug/L
Standard Deviation 21.92
|
25.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Week 2 (Predose)
|
1.9 ug/L
Standard Deviation 2.15
|
1.4 ug/L
Standard Deviation 1.14
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Week 2 (Postdose)
|
16.3 ug/L
Standard Deviation 9.54
|
21.0 ug/L
Standard Deviation 1.41
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Week 4 (Predose)
|
2.7 ug/L
Standard Deviation 2.92
|
3.3 ug/L
Standard Deviation 2.63
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Week 4 (Postdose)
|
6.5 ug/L
Standard Deviation 6.36
|
4.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Week 12 (Predose)
|
3.6 ug/L
Standard Deviation 3.36
|
7.5 ug/L
Standard Deviation 5.69
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Week 12 (Postdose)
|
51.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
4.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Week 16 (Postdose)
|
39.2 ug/L
Standard Deviation 30.60
|
59.8 ug/L
Standard Deviation 40.07
|
SECONDARY outcome
Timeframe: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16Population: Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.
Reported data were observed plasma concentration for Azilsartan Metabolites (M-II) for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.
Outcome measures
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 Participants
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 Participants
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Week 8 (Postdose)
|
175.5 ug/L
Standard Deviation 78.49
|
110.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Week 2 (Predose)
|
53.3 ug/L
Standard Deviation 61.31
|
41.4 ug/L
Standard Deviation 28.66
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Week 2 (Postdose)
|
158.3 ug/L
Standard Deviation 102.88
|
129.0 ug/L
Standard Deviation 26.87
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Week 4 (Predose)
|
71.1 ug/L
Standard Deviation 77.05
|
90.8 ug/L
Standard Deviation 40.99
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Week 4 (Postdose)
|
186.0 ug/L
Standard Deviation 214.96
|
69 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Week 8 (Predose)
|
113.8 ug/L
Standard Deviation 140.23
|
124.0 ug/L
Standard Deviation 78.25
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Week 12 (Predose)
|
106.2 ug/L
Standard Deviation 144.85
|
180.0 ug/L
Standard Deviation 147.97
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Week 12 (Postdose)
|
184.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
86.0 ug/L
Standard Deviation NA
Standard deviation was not calculated for 1 participant.
|
|
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Week 16 (Postdose)
|
311.0 ug/L
Standard Deviation 480.62
|
423.6 ug/L
Standard Deviation 277.62
|
Adverse Events
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 participants at risk
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 participants at risk
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Immune system disorders
Kidney transplant rejection
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Varicella
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
Other adverse events
| Measure |
Azilsartan 2.5 - 20 mg (Weight < 50 kg)
n=22 participants at risk
Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing \< 50 kg.
|
Azilsartan 5 - 40 mg (Weight ≥ 50 kg)
n=5 participants at risk
Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg.
|
|---|---|---|
|
Infections and infestations
Lice infestation
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Hordeolum
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Mumps
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Parotitis
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Streptococcal infection
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Tinea manuum
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Injury, poisoning and procedural complications
Ear injury
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Injury, poisoning and procedural complications
Human bite
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Investigations
Blood creatinine increased
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Investigations
Protein urine present
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Investigations
White blood cell count increased
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Nervous system disorders
Dizziness
|
13.6%
3/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Renal and urinary disorders
Renal impairment
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Renal and urinary disorders
Dysuria
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Skin and subcutaneous tissue disorders
Leukoderma
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Vascular disorders
Orthostatic hypotension
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Eye disorders
Dry eye
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Gastrointestinal disorders
Constipation
|
13.6%
3/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
3/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Gastrointestinal disorders
Enteritis
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
General disorders
Pyrexia
|
13.6%
3/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
General disorders
Chest pain
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
General disorders
Malaise
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
General disorders
Vessel puncture site bruise
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Immune system disorders
Seasonal allergy
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
40.9%
9/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
40.0%
2/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Gastroenteritis
|
18.2%
4/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Influenza
|
13.6%
3/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
20.0%
1/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Otitis media
|
13.6%
3/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Sinusitis
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
2/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Adenoiditis
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Adenovirus infection
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Bronchitis
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Conjunctivitis
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
|
Infections and infestations
Coxsackie viral infection
|
4.5%
1/22 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
0.00%
0/5 • From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER